MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 49; HIP FEMORAL HEAD

Catalog Number 999890249

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 02/08/2019

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.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.

Event Description

Litigation record received.Asr depuy was implanted.Patient alleges injury, pain, suffering, emotional distress,economic loss, loss of services, loss of consortium, toxic cobalt and chromium metal ions and particles were released into plaintiff¿s blood, tissue and bone surrounding the implant and pseudotumors.Doi: (b)(6) 2008; dor: (b)(6) 2019 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: udi: (b)(4).No code available (3191) used to capture the device revision or replacement 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records patient was revised to addressed failed left total hip arthroplasty with pseudotumor and metallosis.Operative notes indicated corrosion at the trunnion taper and minimal bone loss.Added medical history, age of patient, product details of cup, head, sleeve and stem.Also added srom sleeve in impacted products.Corrected patient's initial.Doi: (b)(6) 2008 dor: (b)(6) 2019 left hip.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 49
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9957680
• MDR Text Key: 187564209
• Report Number: 1818910-2020-10737
• 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: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 999890249
• Device Lot Number: 2549807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +6.; ASR ACETABULAR CUPS 56.; S-ROM*SLEEVE PRX ZTT, 18D-LRG.; SROM*STM ST,36+8L NK,18X13X160.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR