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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Nonstandard Device (1420); Biocompatibility (2886)

Patient Problems Death (1802); Renal Failure (2041); Obstruction/Occlusion (2422); Test Result (2695); No Code Available (3191)

Event Date 01/17/2014

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Reporter is an attorney.

Event Description

The patient was told that he had to be revised because (literally) the devices implanted were toxic.Also, in the report the lawyer reported that likewise asr case, the cr-co resulted in the patient blood as per blood test performed on (b)(6) 2012.On 17 jan 2014 (b)(6) have confirmed the product is an asr product.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP 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 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; st. anthony's road; leeds LS11 -8DT ; UK LS11 8DT ; 6103142063
• MDR Report Key: 8128479
• MDR Text Key: 129173555
• Report Number: 1818910-2018-77034
• Device Sequence Number: 0
• Product Code: JDI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR