MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS NON-MOD TIB PLATE LONG 71 LONG; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01099 and 0001825034-2021-01100.Medical product: oss 3cm resurf femoral lt, item# 150351, lot# 578530; oss cemented im stem 17x150 50, item# 150371, lot# 818190; oss axle, item# 150480, lot# 415380; oss poly lock pin, item# 150478, lot# 489220; oss poly tibial bushing, item# 150476, lot# 303530; oss poly femoral bushings, item# 150477, lot# 140070; oss tibial poly bearing 12mm, item# 150410, lot# 368590; oss reinforced yoke, item# 150493, lot# 111640.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised approximately six and a half years post implantation due to femoral and tibial loosening.Attempts to obtain additional information have been made; however, no more information is available.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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.

• Brand Name: OSS NON-MOD TIB PLATE LONG 71 LONG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11673369
• MDR Text Key: 259043400
• Report Number: 0001825034-2021-01098
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161043
• Device Lot Number: 742520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• 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