MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 12X71/75; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Unintended Movement (3026); Noise, Audible (3273)

Patient Problems Tissue Damage (2104); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the part& lot number of the device involved in the event is unknown.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

It was reported that patient underwent left total knee arthroplasty approximately 7 years ago.Subsequently, patient underwent a revision procedure one year later due to instability and periprosthetic soft tissue impingement.The bearing component was removed and replaced with a 4mm thicker constrained one.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.This complaint was confirmed by review of provided medical records.Device history record (dhr) was reviewed and no discrepancies were found.Medical records provided state that residual band of the meniscofemoral ligament extending from adjacent to the pcl and wrapping underneath the lateral femoral condyle was extremely taut and potentially was a source of a clicking phenomenon.This meniscofemoral remnant was excised.The popliteus was also noted to be quite taut & bulkier than typical and in the flexion space entered into the joint as opposed to sitting posterior to the joint.Given these findings, recession of the tendon of the popliteus was indicated.The bulk of the popliteus tendon was excised given the thick nature of the tendon.Then, the posterior-more elements of the tendon were fractionally released to allow for lengthening.Clinical release of the tendon was evident.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

It was reported that patient underwent left total knee arthroplasty approximately 7 years ago.Subsequently, patient underwent a revision procedure one year later due to instability, clicking, and periprosthetic soft tissue impingement.Ligament resection and tendon release was performed to remove them from the joint space and the bearing component was removed and replaced with a 4mm thicker constrained one.

• Brand Name: VNGD CR TIB BRG 12X71/75
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11307106
• MDR Text Key: 231133674
• Report Number: 0001825034-2021-00423
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Model Number: N/A
• Device Catalogue Number: 183442
• Device Lot Number: 971540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention