MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 54; HIP ACETABULAR CUP

Catalog Number 999800754

Device Problems Naturally Worn (2988); Osseointegration Problem (3003); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/07/2020

Event Type  Injury  

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.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.

Event Description

Asr xl litigation records received.Litigation alleges pain, injury, elevated cobalt and chromium level, acetabular cup detached/disconnected, metal debris, loosened acetabulum, walking difficulty, grinding and clicking.Doi: (b)(6) 2007 : dor: (b)(6) 2020 (left 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.Device history lot : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Event Description

After review of the medical records, the patient was revised to address failed left total hip arthroplasty secondary to adverse metal on metal reaction and cobalt chromium toxicity.Revision notes reported of moderate alval limited to the capsule and moderate capsular necrosis.It was also indicated that there was a small hip effusion around the femoral neck and mild synovial thickening.Laboratory results showed elevated cobalt serum level.Stem was not revised during revision.Doi: on (b)(6) 2007, dor: on (b)(6) 2020, (left hip).

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: a2 (age, dob), h6 (clinical code).Udi: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ASR ACETABULAR CUPS 54
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11620016
• MDR Text Key: 243971711
• Report Number: 1818910-2021-07168
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999800754
• Device Lot Number: 2316515
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +0.; ASR UNI FEMORAL IMPL SIZE 47.; S-ROM*SLEEVE PRX ZTT, 18D-LRG.; SROM STM STD 36+12L 13X18.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNKNOWN HIP FEMORAL STEM.; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR