MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN DEPUY FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-HIP

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Muscle Weakness (1967); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 07/09/2014

Event Type  Injury  

Event Description

Litigation alleges, the patient suffers from pain, discomfort, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.

Manufacturer Narrative

The devices associated with this report were not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot codes required were not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Update 12 oct 2017: pfs received.It also alleges decreased strength and ability to do recreational activities, and an unstable balance.This complaint was updated on oct 23, 2017.

Manufacturer Narrative

Additional narrative: after review of the medical records, it has been determined that this product has been reported twice.This duplication is an error.This report will be rejected.

• Brand Name: UNKNOWN DEPUY FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 4233103
• MDR Text Key: 5060519
• Report Number: 1818910-2014-31334
• Device Sequence Number: 1
• Product Code: KWY
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2014

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: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: 10/12/2017; 12/13/2017
• Supplement Dates FDA Received: 10/23/2017; 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 88