MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890251

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

Patient Problems Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094); Injury (2348); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Physical Asymmetry (4573)

Event Date 12/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Initial reporter 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

Asr hip mom litigation record received.The litigation alleges severe pain, elevated ions level, loss of wages past and future, trouble sleeping and walking, emotional distress, and other illness and injuries.Asr hip implant was revised due to elevated levels of cobalt and chromium ions, metallosis, adverse reaction to metal debris.Revision operative note mentioned of synovitis and inflammatory tissue.Doi: (b)(6) 2009; dor: (b)(6) 2018 (left 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.Device history lot: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Event Description

Revision notes stated that leg length was about a centimeter short on the left side preop.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 51
• 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: 9897460
• MDR Text Key: 186790908
• Report Number: 1818910-2020-09561
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 999890251
• Device Lot Number: 2859604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2.; ASR 300 SPIKED CUP SIZE 58.; SUMMIT DUOFIX TAP SZ7 HI OFF.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR