MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804956

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Unspecified Tissue Injury (4559)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr revision.Asr resurfacing.Right hip.Reason for revision: component loosening.Doi: (b)(6) 2006; dor: unknown: right hip.

Event Description

Scf alleges revision due to component loosening, pain and osteolysis femoral component.After review of the medical record, the patient was revised due to osteolysis.Operative note reported deficient abductors, acetabulum asr well ingrown and pseudo-osteophytes were excised.Doi: (b)(6) 2006; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Product complaint #
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> (b)(4).Investigation summary
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> investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.Investigation section: previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore, no dhr (device history record) review for this individual asr component will be carried out at this point in time.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.The investigation to determine root cause was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.Root cause category: cause not established.

• Brand Name: ASR ACETABULAR IMPLANT 56
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10967977
• MDR Text Key: 220215553
• Report Number: 1818910-2020-26432
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 999804956
• Device Lot Number: 2158481
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 56; TOTAL ASR FEM IMP SIZE 49; ASR ACETABULAR IMPLANT 56; TOTAL ASR FEM IMP SIZE 49
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR