MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ASR ACETABULAR IMPLANT 52; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804652

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #:(b)(4).Initial 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 xl revision.Reason for revision: pain and swelling at night with severe restriction of movement.Doi: (b)(6) 2008.Dor: (b)(6) 2021.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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, no device history record (dhr) review for this individual asr component will be carried out at this point in time.

• Brand Name: ASR ACETABULAR IMPLANT 52
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12342801
• MDR Text Key: 267281369
• Report Number: 1818910-2021-18184
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999804652
• Device Lot Number: 2546332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• 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 52; CORAIL2 STD SIZE 12; DEPUY ASR XL FEM IMP SIZE 46; TAPER SLEEVE ADAPTER 12/14 +2; ASR ACETABULAR IMPLANT 52; CORAIL2 STD SIZE 12; DEPUY ASR XL FEM IMP SIZE 46; TAPER SLEEVE ADAPTER 12/14 +2
• Patient Outcome(s): Required Intervention