MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT CR ANAT FM L 70M; METAL SENSITIVE VGD CR FMRL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.Associated products: medical product: tnbn pol cocr fin tib tray 79.Catalogue number: 141255tnbn.Lot number: unknown.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: patient revised for instability and patellofemoral pain ¿ patella resurfacing done and changed polyethene tibial bearing into a 12mm anterior stabilized bearing.The surgeon marked the relation to the device as probably, to instrumentation as not related and to a procedure as definitely related.Patient outcome: revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The likely condition of the device when it left zimmer biomet could not be confirmed and the root cause of the reported event cannot be determined with the information provided.It is noted from the information provided that the femoral component remained implanted and the tibial bearing component was exchanged along with a patella resurfacing procedure indicating that the surgeon did not have an issue with the femoral component.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.If any further information is found 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 Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Product has not been returned for evaluation.The femoral component remained implanted and the tibial bearing component was exchanged along with a patella resurfacing procedure indicating that the surgeon did not have an issue with the femoral component.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: per report image from time point one (16jun2011) demonstrates normal patellofemoral alignment on the sunrise view.From time point two (06aug2012) demonstrates grossly normal and expected post op revision changes.There is questionable, very subtle medial subluxation of the tibia with respect to the femur on frontal view although this is likely artefact and related to positioning as the skin staples are also noted to be rejected slightly medially.Likely there is anatomic alignment and no complicating features.From time point three (05jan2017) narrowed patellofemoral spacing and slight lateral subluxation of the patella are demonstrated in sunrise view.Other views are relatively normal in appearance and alignment.From the final time point (15jan2017) the bar that was previously present along the tibial plate appears changed and now appears normal with absence of lateral subluxation.There are no other issue or concerns noted.Medical record review performed.Findings: rom: flexion 110°, full extension, noted patella slides laterally therefore lateral release and bony ridge-like patella realignment performed.A definitive root cause cannot be determined.If any further information is found 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 Description

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

• Brand Name: TINBN VG INT CR ANAT FM L 70M
• Type of Device: METAL SENSITIVE VGD CR FMRL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13768646
• MDR Text Key: 287177383
• Report Number: 3002806535-2022-00102
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00887868355486
• UDI-Public: (01)00887868355486(17)211027(10)2499987
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 09/23/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2021
• Device Model Number: N/A
• Device Catalogue Number: 183032TNBN
• Device Lot Number: 2499987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 06/08/2022; 08/25/2022; 09/22/2022
• Supplement Dates FDA Received: 06/14/2022; 09/20/2022; 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 100 KG