MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 43 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890243

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 11/28/2018

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

Asr plaintiff preliminary disclosure received. Ppd has no allegation provided. Doi: (b)(6) 2008; dor: (b)(6) 2018: 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.

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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 43
• 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: 10302115
• Report Number: 1818910-2020-16381
• 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: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 999890243
• Device Lot Number: 2557511
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Age: 62 YR
• Patient Treatment(s): ASR ACETABULAR CUPS 48; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 43; SUMMIT POR TAPER SZ5 STD OFF; UNKNOWN HIP FEMORAL STEM; ASR ACETABULAR CUPS 48; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 43; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention