MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SELF CNTR HIP 44X22.225 GRY; HIP OTHER IMPLANT

Catalog Number 103744000

Device Problems Material Discolored (1170); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address osteolysis and poly wear.It was noted that part of the poly portion of the bipolar was discolored also.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

(b)(4).Examination of the returned femoral head, stem, and a self centering assembly confirmed the black material near the taper connection was likely corrosion product of cocrmo alloy.Crevice corrosion may occur in taper connections and likely corrosion products became visible on the parts after 10 years.No evidence of material or manufacturing defects was observed.A search of the complaints databases identified no other reports against the femoral stem.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.The investigation can draw no conclusions regarding the reported event.Product problem has not been identified.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy still 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.

• Brand Name: SELF CNTR HIP 44X22.225 GRY
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5946053
• MDR Text Key: 54553541
• Report Number: 1818910-2016-27069
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2016

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: 103744000
• Device Lot Number: Y5VDX1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/30/2016; 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 62 YR