MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Malposition of Device (2616)

Patient Problems Ossification (1428); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032)

Event Date 12/13/2006

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this 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.

Event Description

On 02/10/2017 - pfs and medical records received.After review of the medical records for mdr reportability, alleges severe pain, loss of mobility, ankle fusion, foot drop, and left leg amputation.Revising surgeon stated in his indications that the patient had dislocated five times since his last revision, and that on x-rays, the "cup is loose", and "appears to be neutral to retroverted" and that patient has "significant instability".Operatively, surgeon found the cup "grossly loose" and almost vertical and slightly retroverted.Upon removing the liner, rim and dome screws, and the cup, discovered that bone graft that had been beneath the cup in the large acetabular defects was "all dead" and none of it "had become adherent", suggestive of why there was no bony ingrowth of the cup.Also indicated that the existing stem was very well-fixed, but also retroverted about 15 degrees, causing impingement of the trochanter.Identified and removed a lot of heterotopic ossification.Head and liner will be reported for dislocation, and cup and stem will be reported for malposition, the cup also for implant loosening.Heterotopic ossification will be added.Post-operatively, it was discovered that, in spite of the repeated care given to protect the sciatic nerve throughout the procedure, the patient experienced a significant left sciatic nerve injury with resultant palsy.It will be reported as nerve injury.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other related reports against the product and lot code combinations since release to distribution.The search and/or review of device history records were not possible against the unknown product.The investigation can draw no conclusion with the information provided.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.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.

• Brand Name: UNKNOWN DEPUY FEMORAL STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• 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: 6375046
• MDR Text Key: 68964860
• Report Number: 1818910-2017-13900
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2017
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 91