MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR LOCK STANDARD L; APPLIANCE, FIXATION

Model Number	131822050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient was experiencing pain and an abnormal sensation in the wrist approximately 1 year post initial implantation.Subsequently, the plate was removed and the patient still experiences pain.No additional patient consequences are reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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 event information is available at the time of this report.

• Brand Name: DVR LOCK STANDARD L
• Common Device Name: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12025366
• Report Number: 0001825034-2021-01843
• Device Sequence Number: 19680251
• Product Code: LXT
• UDI-Device Identifier: 00880304533462
• UDI-Public: (01)00880304533462
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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 Model Number: 131822050
• Device Catalogue Number: 131822050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR