MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890245

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Physical Asymmetry (4573)

Event Date 04/01/2011

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.

Event Description

Asr medical records received.After review of medical records the patient was revised to address pain and elevated metal ions.Operative note reported efflux of grayish thin fluid, soft tissue metallosis, 1cm area of spot weld noted without any ingrowth and limb asymmetry.Doi: (b)(6) 2009; dor: (b)(6) 2011; left hip.

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.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 will be filed as appropriate.

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.H10 additional narrative: added: b5, b7, d10, e1 (initial reporter facility name) and h6 (clinical and device codes) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Pfs alleges metallosis, blood toxicity, walking and standing difficulty, depression, hair loss, memory loss, problems with balance, and discomfort.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 45
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9588378
• MDR Text Key: 175068290
• Report Number: 1818910-2020-01814
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• 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: 12/30/2019

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: 999890245
• Device Lot Number: 2797975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 02/12/2020; 02/23/2023
• Supplement Dates FDA Received: 02/17/2020; 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: No
• 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 300 SPIKED CUP SIZE 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ2 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female