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

Catalog Number UNK-HIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Muscular Rigidity (1968); Pain (1994); Joint Swelling (2356)

Event Date 09/02/2014

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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges pain, weakness, swelling, stiffness, and elevated metal ion levels.Update der recvd.Updated dor, patient age, surgeon name, sales rep details.Updated cup and head.Added sleeve.Update (b)(6) 2016 medical records received.Medical records reviewed for mdr reportability.Medical records contained primary and revision surgical operative notes but no component stickers or list.Primary surgery noted a summit stem implanted and an unknown summit stem will be reported for the allegation of elevated metal ion levels without lab results.The revision surgical note reported patient revised for pain and surgeon had trouble with acetabular explant using a competitor instrument with excess bone removed with component and bone grafting completed.Comorbidities and expiration dates of known products updated.The complaint was updated on: (b)(6) 2016.

Manufacturer Narrative

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.(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.

• Brand Name: UNK SUMMIT 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: 5460839
• MDR Text Key: 39035428
• Report Number: 1818910-2016-14051
• 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: 02/01/2016

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: UNK-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• 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): Required Intervention
• Patient Age: 52 YR