MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ8 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number	157012150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994)
Date of Event	07/19/2017
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
Patient was revised to address pain.It was also reported that the patient had hip fracture in may of this year and now suffering a terrible infected right hip joint.The surgeon removed all depuy components, reamed the femoral canal, irrigated the wound with copious amounts of antibiotic saline solution and implanted approximately 12 cc of antibiotic beads.
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 will be filed as appropriate.
Event or Problem Description
Complaint description: patient was revised to address pain.It was also reported that the patient had hip fracture in may of this year and now suffering a terrible infected right hip joint.The surgeon removed all depuy components, reamed the femoral canal, irrigated the wound with copious amounts of antibiotic saline solution and implanted approximately 12cc of antibiotic beads.

• Brand Name: SUMMIT DUOFIX TAP SZ8 HI OFF
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6804116
• Report Number: 1818910-2017-23080
• Device Sequence Number: 16574984
• Product Code: LPH
• UDI-Device Identifier: 10603295060192
• UDI-Public: 10603295060192
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 157012150
• Device Lot Number: C53382
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 05/18/2018
• 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: 45 YR
• Patient Weight: 64