MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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).Attorney.

Event Description

The patient was implanted with an unknown model of proxima device on (b)(6) 2007.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 (b)(6) 2014, (b)(6) have confirmed the product is an asr product.Update 31 oct 2018.Claim letter received for pending english translation.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: revision of the device has been reported and there was no allegation that the device was a contributor to this event.No explanted devices have been received in respect of this patient for analysis.If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8128473
• MDR Text Key: 129173089
• Report Number: 1818910-2018-77031
• 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,Followup
• Report Date: 11/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/10/2019
• 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): Death
• Patient Age: 67 YR