MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ACCLAIM LINKED POLY HUM YOKE; ACCLAIM ELBOW IMPLANT : ELBOW HUMERAL YOKE

Catalog Number	172285000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	05/22/2019
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
It was reported that the device was starting to break down and causing pain and loss of motion.Doi: (b)(6) 2005.Dor: (b)(6) 2019.Affected side: left elbow.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: ACCLAIM LINKED POLY HUM YOKE
• Common Device Name: ACCLAIM ELBOW IMPLANT : ELBOW HUMERAL YOKE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8691444
• Report Number: 1818910-2019-95777
• Device Sequence Number: 1924783
• Product Code: JDB
• UDI-Device Identifier: 10603295067658
• UDI-Public: 10603295067658
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K992656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 172285000
• Device Lot Number: ZP8B41000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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: 60 YR