MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD 8010379 UNKNOWN DEPUY STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/21/2015

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.See report for any product information received.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Litigation papers allege the patient suffered symptoms including, but not limited to, pain which has increased from intermittent to continuous, soreness and difficulty walking.Patient has also suffered from elevated cobalt and chromium levels; however, his physicians have advised against revision surgery at this time.

Manufacturer Narrative

Litigation papers allege the patient suffered symptoms including, but not limited to, pain which has increased from intermittent to continuous, soreness and difficulty walking.Patient has also suffered from elevated cobalt and chromium levels; however, his physicians have advised against revision surgery at this time.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.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.

Manufacturer Narrative

Depuy still considers this investigation closed at this time.

Event Description

Update 4/6/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, swelling, audible clicking bilaterally, difficulty breathing, loss of energy, shortness of breath, and increased eyesight loss.Medical records received were for the right hip primary surgery only.Patient harms updated.The complaint was updated on: apr 29, 2016.

• Brand Name: UNKNOWN DEPUY STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5324167
• MDR Text Key: 34268094
• Report Number: 1818910-2015-38190
• 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,Followup
• Report Date: 12/21/2015

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: Physician
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2016; 04/29/2016
• 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
• Patient Age: 51 YR
• Patient Weight: 91