MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 43; METAL FEMORAL HEAD

Catalog Number 999890243

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Renal Failure (2041); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.The device catalog number is unknown; therefore, udi is unavailable.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr xl litigation complaint received ad 3 jan 2023.Patient was revised due to pain, discomfort, increase metal levels in blood including cobalt and chromium, permanent injuries, emotional distress, disability and disfigurement.Doi: (b)(6) 2006.Dor: (b)(6) 2022.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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Event Description

Plaintiff fact sheet received.After review, the patient was revised due to hip pain caused by walking and standing, chromium and cobalt metal levels were tested and were found to be high, metallosis, and corrosion was found at the taper according to surgeon, sleeping difficulties in which laying on my right side caused it.The patient was feeling angry and have anxiety about all of the damage that the asr has caused and about any future damage the metallosis may cause and also concerned that the elevated levels of chromium and cobalt caused damage to his kidneys and other organs.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 43
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16156724
• MDR Text Key: 307268079
• Report Number: 1818910-2023-01130
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

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: 05/31/2011
• Device Catalogue Number: 999890243
• Device Lot Number: 2171089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 03/03/2023; 05/12/2023
• Supplement Dates FDA Received: 03/03/2023; 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2.; ASR ACETABULAR CUPS 48.; REPLICA LG STAT SHT LT 10.5MM.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 90 KG