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

Catalog Number	157002090
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Litigation alleges that the patient suffers from pain, discomfort, inflammation, and difficulty ambulating.Update: 5/21/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified by invoice search.Records are available for further review.Doi: (b)(6) 2006 - dor: none reported (left hip).Update ad 30 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf with sticker sheets and medical records.Ppf alleges elevated metal ions.After review of medical records, it provided only the implant record.The event description has been updated to indicate the allegations as reviewed.Updated product details and the date of revision.Doi: (b)(6) 2006 - dor: (b)(6) 2017 (left hip).
Additional Manufacturer Narrative
(b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7718463
• Report Number: 1818910-2018-65186
• Device Sequence Number: 1452143
• Product Code: LPH
• UDI-Device Identifier: 10603295059448
• UDI-Public: 10603295059448
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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 Catalogue Number: 157002090
• Device Lot Number: ZP2FC1000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: 57 YR
• Patient Weight: 101