MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; METAL ACETABULAR LINER

Catalog Number 121887458

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 02/09/2022

Event Type  Injury  

Event Description

Pinnacle mom litigation records received.Litigation alleges heavy metal poisoning due to elevated metal ions resulting to injury to the muscles, tissues, metallosis, scar tissue formation, limited adl, emotional trauma, distress and pain.Doi: (b)(6) 2009.Dor: (b)(6) 2022.Hip unknown.

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

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 record evaluation (mre), was not possible because the required lot code was not provided.

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 : 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.H6 clinical codes: metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.Unspecified tissue injury (e2015) is used to capture bone injury and soft tissue injury.

Event Description

After review of medical record, patient was revised to address pain, metal on metal reaction with pseudotumor.Patient had elevated metal ion.Revision notes stated that he had a large effusion within the joint.He was noted to have corrosion at the stem head junction by the trunnion.We then debrided the anterior fibrous tissue fibrous tissue extended anteriorly toward the pelvic rim large amount of pseudotumor was then removed from the anterior aspect of the joint.The cu was removed with minimal bone loss.Doi: (b)(6) 2009, dor: (b)(6) 2022, affected side: left hip.

Event Description

Medical records received.In addition to what was previously reported in medical records after review of the records the patient was revised to address cup had a neutral version compared to the spine and cup removed with minimal bone loss and lysis.Prior to the explantation of the cup noted to have lost much of the anterior wall of the acetabulum.Instability with the existing cup.Clinical visit reported hip pain, walking difficulty, trochanteric bursitis, osteophyte over left greater trochanter, osteophyte formation over acetabulum, joint stiffness, tenderness, positive for depression, bruising, stress and sleep disturbance.Pathology report synovium, pseudotumor, fibrosis, hemosiderin laden macrophages, patchy mild lymphoplasmacystic inflammation and metallosis.

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.H6: distress (e020203) is being utilized to capture stress & emotional distress.Inflammation (e2326) is being utilized to capture inflammation & bursitis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of the x-ray evidence provided found, nothing indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed, for the finished device (121887458/2797868) product and lot numbers.And no non-conformances were identified.Device history review: a manufacturing record evaluation was performed, for the finished device (121887458/2797868) product and lot numbers.And no non-conformances were identified.

• Brand Name: PINNACLE MTL INS NEUT40IDX58OD
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15084446
• MDR Text Key: 296388535
• Report Number: 1818910-2022-13699
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/22/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 121887458
• Device Lot Number: 2797868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 03/16/2023; 05/22/2023; 08/08/2023
• Supplement Dates FDA Received: 07/25/2022; 03/22/2023; 06/05/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC-2; APEX HOLE ELIM POSITIVE STOP; PINN SECTOR W/GRIPTION 58MM; TRI-LOCK BPS SZ 8 STD OFFSET; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 64 KG