MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Swelling (2091); Osteopenia/ Osteoporosis (2651)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had a total knee arthroplasty and 42 months after the procedure the patient felt a sharp pain and swelling and was revised due to a tibial bearing fracture.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

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, d11, g4, g7, h1, h2, h3, h6, h10 d11: item 150493 lot 254670, item 150476 lot 510930, item 150480 lot 745700, item 11-150822 lot 961580, item 161043 lot 826550, item 150477 lot 170160, item 150478 lot 979820, item 150466 lot 012560, item 150446 lot 517770.Visual examination of the returned bearing found signs of being implanted wear/discoloration and is fractured.Device was submitted for further analysis.Analysis determined the articular surface fracture was potentially caused by gradual penetration of the yoke into the material due to pulling forces in extension, followed by subsequent fracture due to potential overloading and the reduced bearing material and possibly exacerbated by m/l misalignment resulting in keyway impingement, overloading, and abrasion wear on one side.Review of the device history record(s) identified no deviations or anomalies during manufacturing.X-rays were provided and reviewed by a health care professional.Review found sharply marginated hypodense object within the posterior knee joint and a joint effusion.This most likely represents a displaced polyethylene implant.Bone quality appears osteopenic.Patient anatomy appears unremarkable.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.

Event Description

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

• Brand Name: OSS TIBIAL POLY BEARING 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10379442
• MDR Text Key: 202038330
• Report Number: 0001825034-2020-03066
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

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: 04/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 150410
• Device Lot Number: 755910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 01/07/2021
• Supplement Dates FDA Received: 09/03/2020; 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN FEMORAL COMPONENT; UNKNOWN TIBIAL COMPONENT; UNKNOWN FEMORAL COMPONENT; UNKNOWN TIBIAL COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 70