MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 43; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890143

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Tissue Damage (2104); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the patient had a corail stem with a 48mm asr cup implanted in 2007.Patient recently dislocated her hip.Hip was reduced in the er and patient was scheduled for a cup and head revision.Stem was left in place.Both stem and cup were well fixed at the time of revision surgery.Asr cup and head were replaced with a pinnacle cup and ts ceramic head.Surgeon stated intra-op there was significant tissue metal staining.Doi: unknown; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 43
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8640088
• MDR Text Key: 146058573
• Report Number: 1818910-2019-94517
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999890143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR