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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Biocompatibility (2886)

Patient Problems Death (1802); Renal Failure (2041); Obstruction/Occlusion (2422); Test Result (2695)

Event Date 01/17/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).

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 17 jan 2014 (b)(4) have confirmed the product is an asr product.On 13 feb 2014 - response received from both kennedy & crawford that no further information is available at this point.Close the com until further information is available.

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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• 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: 8128433
• MDR Text Key: 129169164
• Report Number: 1818910-2018-77027
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2019
• 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