MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that, during a total knee arthroplasty, the surgeon found that there was a gap between the articular surface and tibia stem component after insertion.The connecting part of the tibia stem fractured when the articular surface was inserted and pushed by the surface inserter.Subsequently, the articular surface was tapped to insert.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: tibia cemented 5 degree stemmed left size c, item#: 42532006401, lot#: 65121055.Report source- (b)(6).Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned fragments confirmed that a part of a tibial stem was broken.Sem analysis further confirmed that a shear ductile overload fracture occurred breaking the fragment from the rest of the part.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no 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.

Event Description

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

• Brand Name: ARTICULAR SURFACE FIXED BEARING (PS) LEFT 11 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13108458
• MDR Text Key: 282911252
• Report Number: 3007963827-2021-00330
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024237094
• UDI-Public: (01)00889024237094(17)260618(10)65066941
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512400511
• Device Lot Number: 65066941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Female