MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ3 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number	157012090
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On (b)(6) 2015: medical records received.After review of the medical records for the mdr reportability, patient was revised due to soft tissue necrosis and granuloma from metal on metal.Clinical notes reported of pain and discomfort.Mri showed a large amount of peri-prosthetic fluid over the greater trochanter and in the anterior hip bursa which representing alval and indicative of reaction to metal wear.X-ray stated that there is a bone heterotopic new bone formation lateral to the hip and also new bone formation at superomedial aspect of the acetabular cup.Laboratory results for cobalt were above 7ppb.Product codes and lot numbers provided.
Additional Manufacturer Narrative
Medical records received.After review of the medical records for the mdr reportability, patient was revised due to soft tissue necrosis and granuloma from metal on metal.Clinical notes reported of pain and discomfort.Mri showed a large amount of peri-prosthetic fluid over the greater trochanter and in the anterior hip bursa which representing alval and indicative of reaction to metal wear.On (b)(6)2015, notes stated there is 1-2 cm shortening in the left leg.X-ray stated that there is a bone heterotopic new bone formation lateral to the hip and also new bone formation at superomedial aspect of the acetabular cup.Laboratory results for cobalt were above 7ppb.Product codes and lot numbers provided.The reported event has been evaluated and will be monitored.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ3 HI OFF
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6762826
• Report Number: 1818910-2017-22111
• Device Sequence Number: 2014232
• Product Code: LPH
• UDI-Device Identifier: 10603295060147
• UDI-Public: 10603295060147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2011
• Device Catalogue Number: 157012090
• Device Lot Number: AA5B21000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 10/08/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR