MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 6; STEM

Catalog Number	157006120
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/26/2017
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
Der states pt had original surgery (b)(6) 2017.On (b)(6) 2017 pt had head and liner exchange for infection.Pt still infected so surgeon removed all components and put in antibiotic spacer.It also state that patient was revised to address loosening of the femoral stem at the cement to implant interface.Unknown cement is used.Doi: (b)(6) 2017; dor: (b)(6) 2017; head and liner: (b)(6) 2017; left hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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 BASIC CEMENTED SZ 6
• Common Device Name: STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7125117
• Report Number: 1818910-2017-51849
• Device Sequence Number: 11102328
• Product Code: JDI
• UDI-Device Identifier: 10603295059790
• UDI-Public: 10603295059790
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K023453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2017

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 Catalogue Number: 157006120
• Device Lot Number: D16070441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2017
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 08/27/2018
• 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: 69 YR
• Patient Weight: 135