MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 48; ASR ACETABULAR CUP

Catalog Number 999804348

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Loosening of unknown components has been alleged.There is insufficient information to determine which components were loose.Therefore, no components will be coded for loosening at this time.If/when more information is received regarding what component is loose, a supplemental med watch report will be sent.Reporter 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 xl acetabular system, right hip.Reason(s) for revision: excessive wear secondary to loosening of an unspecified component(s).Doi: (b)(6) 2008, dor: (b)(6) 2021, 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.Device history lot : 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, if lot codes are provided, no mre (device history record) review or complaint database search for this individual asr component will be carried out at this time.

• Brand Name: ASR ACETABULAR IMPLANT 48
• Type of Device: ASR ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11244231
• MDR Text Key: 229132756
• Report Number: 1818910-2021-01990
• 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: foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999804348
• Device Lot Number: 2507908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• 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 48; DEPUY ASR XL FEM IMP SIZE 43; SUMMIT POR TAPER SZ4 STD OFF; TAPER SLEEVE ADAPTER 12/14 +2; ASR ACETABULAR IMPLANT 48; DEPUY ASR XL FEM IMP SIZE 43; SUMMIT POR TAPER SZ4 STD OFF; TAPER SLEEVE ADAPTER 12/14 +2
• Patient Outcome(s): Required Intervention