MAUDE Adverse Event Report: DEPUY INTL., LTD. ¿ REG. # 8010379 J-FX BIPOL SHEL&22.225LNR/48MM; HIP OTHER IMPLANT

Catalog Number 855748

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body Reaction (1868)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Revision took place due to the bipolar cup¿s migration.Erosion and necrotic tissues were found around the neck.The surgeon suspected armd might have caused this symptom.

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

Device available for evaluation this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

A review of complaints databases and manufacturing records did not identify any anomalies.The returned parts were transferred to applied research for visual inspection and a report was received stating: self centering hip shows no unusual wear.Some retrieval damage is noted across the bearing surface.The back face of the liner could not be assessed as the liner remains locked in the metal self centering head component.No corrective action is required.It was unlikely that a manufacturing defect was present.Post market surveillance per (b)(4).The mode of failure of the prosthesis multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables i.E.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the finding of review of the explants and information as supplied at the time of evaluation.Any conclusions from this data have to be placed into context with all other relevant factors.The complaint shall be closed with an undetermined conclusion and entered into the complaints system and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.

• Brand Name: J-FX BIPOL SHEL&22.225LNR/48MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4903044
• MDR Text Key: 6537532
• Report Number: 1818910-2015-25386
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK980801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2012
• Device Catalogue Number: 855748
• Device Lot Number: 2466160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Date Device Manufactured: 10/09/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention