MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SUMMIT BASIC CEMENTED SZ 6; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157006120
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/10/2018
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
Der states that this patient's femoral stem was revised, from a summit basic cemented stem to an 8" solution stem, due to a periprosthetic fracture of the proximal femur.The periprosthetic fracture occurred during the implantation of the primary stem six days earlier.The scrub tech initially mixed a insufficient amount of bone cement for the implantation of the summit basic stem.By the time a second batch of cement was mixed and inserted into the patient's femoral canal, the initial cement had already begun to harden.During the surgeon's attempt the drive the stem distally through the hardening cement, the distal tip of the stem broke through the side wall of the femur.A distally fixed stem was used during this revision procedure to replacement the original cemented stem.A replacement bi-polar femoral head was also utilized during the revision procedure.It was also stated that the stem was loose at unknown interface and a depuy cement was used.Doi: (b)(6) 2015; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint # (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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT BASIC CEMENTED SZ 6
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7575159
• Report Number: 1818910-2018-61520
• Device Sequence Number: 16197536
• Product Code: JDI
• UDI-Device Identifier: 10603295059790
• UDI-Public: 10603295059790
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K023453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 157006120
• Device Lot Number: D16043653
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: 76 YR