MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890251

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

Patient Problems Cyst(s) (1800); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 06/06/2017

Event Type  Injury  

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 Description

The patient was revised for unknown reason.Asr products were revised.Update ad 05 feb 2020.(b)(4) has been reopened under (b)(4) due to receipt of asr litigation records alleging injury, economic loss, suffering, discomfort, soreness, swelling, severe metallosis, pseudotumors, malaise, loss of energy, immobilization, acute localized damage to tissue and/or bone, mental pain and suffering, excessive levels of chromium and cobalt, pain and emotional distress.Doi: (b)(6) 2006.Dor: (b)(6) 2017, (left hip).Update ad 10 feb 2020.Plaintiff's preliminary disclosure and medical records received.There are no allegations from the ppd.After review of medical records, the patient was revised to address right hip mechanical failure.Patient was experiencing pain, metal on metal reaction and lysis.Intraoperatively, there was a large amount of fluid within the hip, a large cystic like mass consistent with a pseudotumor, lytic areas and mild trunnions around the trunnion.Doi: (b)(6) 2006.Dor: (b)(6) 2017, (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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 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: h6 (patient) and d11.No code available is used to capture generalized illness.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 51
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9746673
• MDR Text Key: 181772523
• Report Number: 1818910-2020-05802
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890251
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR