MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BASE COMPONENT SIZE 4 ORANGE FOR USE WITH SIZE 4 TALAR COMPONENTS ONLY; PROSTHESIS, EXTREMITIES

Catalog Number 00830004400

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00830002400; lot# 64506018.Item# 00830005404; lot# 64166722.Report source: foreign - event occurred in sweden.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.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 Description

It was reported that the patient underwent a revision surgery approximately seven (7) months post-implantation due to pain and failure of the device to osseointegrate.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

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.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d4; g3; g6; h1; h2; h4 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 Description

No further event information available at the time of this report.

• Brand Name: TIBIAL BASE COMPONENT SIZE 4 ORANGE FOR USE WITH SIZE 4 TALAR COMPONENTS ONLY
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14918433
• MDR Text Key: 295310516
• Report Number: 0001822565-2022-01990
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024405059
• UDI-Public: (01)00889024405059(17)310501(10)65019370
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00830004400
• Device Lot Number: 65019370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female