MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 53; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890153

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

Patient Problems Headache (1880); Metal Related Pathology (4530)

Event Date 09/26/2011

Event Type  Injury  

Event Description

Patient has advised they had a a cup and ball implanted into their hip in 2007 and believe that they have heavy metal poisoning which is causing bad headaches.

Manufacturer Narrative

Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 53
• 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 INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15609447
• MDR Text Key: 301814632
• Report Number: 1818910-2022-20479
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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: 999890153
• Device Lot Number: 2380319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2007
• 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: ASR ACETABULAR IMPLANT 60; DEPUY ASR XL FEM IMP SIZE 53; SUMMIT DUOFIX TAP SZ5 HI OFF; SUMMIT DUOFIX TAP SZ5 HI OFF; TAPER SLEEVE ADAPTER 12/14 +2
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male