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

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi #: (b)(4).Concomitant medical devices: item 161034 lot 738430; item 150476 lot 702490; item 150478 lot 772840; item 150493 lot 213480; item 161035 lot 258530; item 150805 lot 778110; item 161013 lot 324480; item 150367 lot 742980; item 3020830401-3 lot 833fae0802; item 3020830401-3 lot 833fae0802; item 3020830401-3 lot 833fae0802.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 patient underwent oss procedure and subsequently eleven months after the procedure the patient was revised due to precise wear of polyethylene and infection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Implant fracture was confirmed.Visual examination of the returned bearing found damage (gouges and scratches) and is cracked/fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined for the articular surface fracture.The root cause of the infection was determined to not be device related.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 RS POLY TIBIAL BEARING 12
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10494774
• MDR Text Key: 205695625
• Report Number: 0001825034-2020-03419
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2022
• Device Model Number: N/A
• Device Catalogue Number: 161028
• Device Lot Number: 355510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• 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