MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936452
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation or Postural Difficulties (2544); Fibrosis (3167); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pinnacle litigation record received.Litigation alleges friction and wear between cobalt-chromium head and liner causing elevated metal ions and particles in plaintiff blood, tissue and bone resulting to inflammation, mental and emotional injuries, pain and discomfort when ambulating.Doi: (b)(6) 2010; dor: (b)(6) 2020; left hip.
Event or Problem Description
After review of medical records the patient was revised due to wear of articular bearing of internal prosthetic left hip joint.Clinical visit reported left hip pain, grinding sensation with pain in her groin, fatigue, tenderness over the groin, restricted range of motion, depression, anxiety, sleep disorder and numbness.Alleged elevated metal ions however cobalt and chromium blood result shows below 7 ppb.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a2 (age), b5, b7, d2b, d4 (procode,lot,udi), g4, h4 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2, d10 and h6 (device).From metal worn to polyethylene worn.
Event or Problem Description
Addition to what were reported in the medical records, after review the patient was revised to address fractured polyethelene, shortening of the leg, limited adl swelling and metallosis.Operative note reported subluxation of the femoral head, disassociated liner from the shell with spin out.Metal head had been rubbing on the titanium shell.There was copious amounts of black fluid erupted.The capsule had a small 1 cm defect.Black synovium in the iliopsoas tension sheath was debrided.Surgical pathology reported foreign body reaction, benign fibrous capsule with slight chronic inflammation and deposit of exogenous pigment adherent fibrin and anemia.X-ray reported polyethylene fracture.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
The pfs mentions: tissue damage, deep venous thrombosis, pulmonary embolism, antiphospholipid syndrome, need for chronic anticoagulation therapy, at risk for a multitude of issues including falls, two secondary revision surgeries to replace the faulty devices, extensive rehabilitation, economic loss, pain and suffering that began in 2011.The pfs mentioned continued pain and unable to lift right leg due to pain and limitations in movement of right hip due to metallosis and tissue damage.On (b)(6) 2010, patient had a left hip arthroplasty to address degenerative joint disease.Depuy components were implanted during this procedure.The patient had a discharge diagnosis of acute blood loss anemia, status post left total hip arthroplasty.Depuy products were placed during this procedure.On (b)(6) 2010, the patient had a right hip arthroplasty to address degenerative joint disease.Depuy components were used during this procedure.(b)(6) 2019 medical records note patient is returning for follow-up for right hip.Patient has had severe groin pain.Medical condition includes: phlebitis, pulmonary embolism.*no mention of when the pulmonary embolism occurred.On (b)(6) 2019, the patient had a partial revision right hip, acetabular component with femoral head exchange to address polyethylene failure, metallosis of the right hip.The surgeon reported finding areas of bare bone on the femoral head and acetabulum with marked osteophytes on the acetabulum.During the procedure the surgeon observed blackish synovial fluid, black tissue.The liner was noted to be loose in the cup and had fractured.The cup and stem were not revised.Femoral head removed without allegation of deficiency.On (b)(6) 2020, the patient had a partial revision of left hip, including femoral head and acetabular polyethylene, to address polyethylene failure.Prior to surgery the patient experienced pain in the left hip along with a sensation of grinding.Radiographs are reported to show a fractured polyethylene liner.During the procedure the surgeon observed black fluid, black tissue.The liner was disassociated from the shell and the femoral head was rubbing against the anterior of the acetabular cup.The liner/head were revised, the cup and stem remained in-situ.Depuy components were used during this procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for device, it could be observed, that acetabular cup and femoral head are having unintended interaction.It is most likely probable, that poly liner and acetabular cup were disassociated.It could be determined, that interlock feature edge of the poly liner experienced damage/ fracture causing, the disassociation event with acetabular cup.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected/re-captured: h6: (clinical code) appropriate term/code not available (e2402).Has been replaced with depression (e020202).
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received: there were no new allegations for the left hip.
Additional Manufacturer Narrative
Product complaint (b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: corrected:: d4 primary udi number if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records received: on (b)(6) 2020, the patient had a left hip revision of femoral head and polyethylene liner and synovectomy.Liner disassociation.Prior to surgery, the patient reported shooting pain and a sensation of metal-on-metal grinding in the left hip.Preoperative x-rays are reported to show a fractured poly liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: corrected: e1 (facility name).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN MAR +4 NEUT 36IDX52OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 -098
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581--098 ; 6107428552
• MDR Report Key: 11164503
• Report Number: 1818910-2021-00986
• Device Sequence Number: 2688712
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121936452
• Device Lot Number: C6EGW1000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/15/2021; 02/01/2021; 02/26/2021; 05/24/2022; 12/14/2022; 01/17/2023; 05/09/2024; 09/05/2024; 11/06/2024; 11/27/2024; 01/23/2025; 05/08/2026; 08/28/2026; Not provided
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/18/2021; 02/10/2021; 02/28/2021; 06/08/2022; 12/15/2022; 01/18/2023; 06/03/2024; 09/12/2024; 11/15/2024; 12/02/2024; 01/28/2025; 05/11/2026; 08/31/2026; 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 52MM; TRI-LOCK BPS SZ 5 STD OFFSET; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male