MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890245

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical record received.After review of medical record, patient was revised to address aseptic loosening, pain, and wear.Revision notes stated that the head was removed.Acetabular component was not overtly loose at the bone implant interface but was removed.Bone loss was noted.Operative findings noted that acetabular implant was loose and noted metallosis.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.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 45
• 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: 10697459
• MDR Text Key: 211893496
• Report Number: 1818910-2020-22727
• 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
• Report Date: 10/02/2020

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 Expiration Date: 04/30/2013
• Device Catalogue Number: 999890245
• Device Lot Number: 2597139
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: 3L92602; ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 50; 3L92602; ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 50
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR