MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT CEMENTED STEM SZ6 HI; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157013120
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: unknown hip femoral head; unknown hip acetabular.Liner; unknown hip acetabular cup; summit cemented stem sz6 hi femoral stem.
Event or Problem Description
Failed left hip.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT CEMENTED STEM SZ6 HI
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7850099
• Report Number: 1818910-2018-68520
• Device Sequence Number: 1263612
• Product Code: JDI
• UDI-Device Identifier: 10603295060253
• UDI-Public: 10603295060253
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 157013120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: 78 YR
• Patient Weight: 81