MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 PROXIMA STD OFFSET R SZ 6; HIP FEMORAL STEM/SLEEVE

Catalog Number 940050016

Device Problems Loss of or Failure to Bond (1068); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); No Information (3190)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

New legal claim received from (b)(6).Xl system.Right hip.Revision has not taken place yet.(b)(4).

Manufacturer Narrative

Further evaluation of the product code indicates that this particular size was not regulated to be sold in the us.Therefore, this report is being rejected.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should the 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.

Manufacturer Narrative

New legal claim received from (b)(6) xl system right hip: revision has not taken place yet.(b)(4).Update alert date (b)(6) 2016.Attached scf, added revision date, added reasons for revision x 3 , added surgeons x 2 , added additional hospital, added full sleeve details and product code for stem, added manufacturing date for sleeve.Taken from scf dated (b)(6) 2016 and claimsuite dated (b)(6) 2016.Reason(s) for revision: component loosening : cup, osteolysis and metallosis.Update june 30, 2017 additional information received from (b)(6), date of revision: (b)(6) 2016.The reported event has been evaluated and will be monitored.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.

• Brand Name: PROXIMA STD OFFSET R SZ 6
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes IN 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5261612
• MDR Text Key: 32540918
• Report Number: 1818910-2015-36382
• 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: consumer,foreign
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2015

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: 940050016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided; 06/30/2017; 07/19/2017
• Supplement Dates FDA Received: 10/28/2016; 07/17/2017; 08/08/2017
• 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): Other