MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 4; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157006100
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/02/2017
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.
Event or Problem Description
The patient was revised to address infection and loosening of the stem at the cement to implant interface.Competitor cement was used.He was brought to surgery for an i&d wash out and uni polar head exchange.During surgery, it was discovered that the cemented stem was loose and had a biofilm, mucus type film around it and needed to be removed.A new smaller stem and uni head were then implanted.Doi: (b)(6) 2017; dor: (b)(6) 2017.Unknown affected side.
Additional Manufacturer Narrative
(b)(4).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 BASIC CEMENTED SZ 4
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7150596
• Report Number: 1818910-2017-52593
• Device Sequence Number: 13719619
• Product Code: JDI
• UDI-Device Identifier: 10603295059776
• UDI-Public: 10603295059776
• 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): 12/02/2017

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: 157006100
• Device Lot Number: D17022203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2017
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 08/24/2018
• 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: 79 YR
• Patient Weight: 86