MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problems Test Result (2695); No Code Available (3191)

Event Date 08/21/2020

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 asr fem head and cup were revised.The doctor had been monitoring pt and he saw an increase in metal ions in her blood.Metal-on-metal allegations against asr platform suggest metal-on-metal debris issues, supported by the observed increase in metal ions in the patient's blood.Doi: (b)(6) 2009, dor: (b)(6) 2020, affected side: unknown.

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: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10516145
• MDR Text Key: 206377654
• Report Number: 1818910-2020-19809
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR