MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PIN/BUSHING REPLACEMENT KIT SMALL/REGULAR; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	32810502501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It is reported that the patient was revised approximately one (1) year and eight (8) months post-implantation due to implant fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D6b: it is unconfirmed whether the patient was revised the same day as the implant breakage; therefore, revision date is updated to unknown.Complaint was reopened for changing revision date to unknown.Root cause of investigation has not changed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed as no device, images, or medical records were received for review.Review of the device history records identified no deviations or anomalies during manufacturing related to the event.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b3; b4; b5; d6b; g3; g6; h1; h2 additional information does not change the root cause of the previous investigation.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 reopened for returned medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: contributing factors of event: - bilateral post-injury omarthrosis - deforming arthrosis right elbow - omalgia (shoulder pain) - shoulder joint contracture findings: - dorsal longitudinal approach - failed fragments of connecting mechanism and liners removed - articulating joint fixed radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: small metallic density displaced fragment located along the posteromedial aspect of the condylar portion of the hardware, possibly chip fracture fragment.Remainder of the hardware appears intact.Soft tissues appear normal.Overall fit and alignment of the implant and bone quality appears normal.Root cause of investigation has not changed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PIN/BUSHING REPLACEMENT KIT SMALL/REGULAR
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13423565
• Report Number: 0001822565-2022-00266
• Device Sequence Number: 3744487
• Product Code: JDC
• UDI-Device Identifier: 00889024273924
• UDI-Public: (01)00889024273924(17)260228(10)63943941
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 32810502501
• Device Lot Number: 63943941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 03/22/2022; 04/25/2022; 05/20/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/31/2022; 05/06/2022; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG