MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROLONG TIBIAL INSERT SZ 4 +2; PROSTHESIS, ANKLE

Catalog Number	00450005402
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: tm ankle tibial base size 4 cat# 00450004400 lot# 64199805; talar component orange size 4 right cat# 00450002400 lot# 63936458; dist lat fib lck plate 6h rt cat#00-2357-017-06 lot#ni; p scr 3 5mmx14mm w/2 7mm hd st cat# 00-2348-014-35 lot#ni - qty 3; p scr 3 5mmx16mm w/2 7mm hd st cat# 00-2348-016-35 lot#ni - qty 2; 3.5mm x 16mm locking screw cat# 00-2359-016-35 lot#ni; 3.5mm x 18mm locking screw cat# 00-2359-018-35 lot#ni; 3.5mm x 20mm locking screw cat# 00-2359-020-35 lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00010, 0001822565-2020-03873.
Event or Problem Description
It was reported that a patient underwent an unknown ankle procedure.Subsequently, the patient has reported pain and impingement issues.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

• Brand Name: PROLONG TIBIAL INSERT SZ 4 +2
• Common Device Name: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11139352
• Report Number: 0001822565-2021-00009
• Device Sequence Number: 14463781
• Product Code: HSN
• UDI-Device Identifier: 00889024269798
• UDI-Public: (01)00889024269798
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K120906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 00450005402
• Device Lot Number: 63655806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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: Other