MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE POROCOAT; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-052
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
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); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
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) 2019, right hip.
Additional Manufacturer Narrative
Product complaint # (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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary device associated with this report was not received for examination.All available x-rays were reviewed.The acetabular cup was noted to have direct contact with the femoral head.Based on the x-ray evidence, it is not unreasonable to conclude that the liner and the cup got disassociated due to a liner fracture.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.
Event or Problem Description
Medical records were received: on (b)(6) 2020 medical records note the patient is experiencing some numbness and tingling down the right leg, along with right groin pain and weakness.On (b)(6) 2021 medical records note patient has been having increased weakness of the iliopsoas muscle right hip, the patient is scheduled for an injection in the iliopsoasa muscle.On (b)(6) 2021 the patient had iliopsoas tendon injection under fluoroscopic guidance to address right hip pain, iliopsoas bursitis, tendonitis.It should be noted that these events happened after the (b)(6) 2019 right hip revision captured on (b)(4).
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.
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.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 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.H11 additional narrative: added: b6.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that : patient's right hip post total hip arthroplasty is reportedly painful with flexion, internal and external rotation, and mild weakness.Right hip fluid in pseudo capsule penetrating posteriorly to greater trochanter superficially.
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 recon described in this report.Added: b5, h6 health effect clinical code.Corrected: b7, d1.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE POROCOAT
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14653335
• Report Number: 1818910-2022-10599
• Device Sequence Number: 4868276
• Product Code: LPH
• UDI-Device Identifier: 10603295008552
• UDI-Public: (01)10603295008552(17)200731(10)E14KG1000
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

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 Expiration Date: 07/31/2020
• Device Model Number: 1217-01-052
• Device Catalogue Number: 121701052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/05/2022; 05/09/2024; 09/05/2024; 01/23/2025; 03/11/2026
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/06/2022; 06/03/2024; 09/13/2024; 01/29/2025; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2010
• 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 +5; PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; TRI-LOCK BPS SZ 5 STD OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male