MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that total knee arthroplasty was performed.Surgeon had a hard time to insert an articular surface in tibia plate.So, he pressed the articular surface to the tibia plate.At the same time, the tibial plate, which was fixed with cement, moved with the patient tibia bone.And the tibia cement fixation loosened.A second tibia was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).Report source: japan.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.Additional associated products & mdrs.42522400411 articular surface fixed bearing posterior stabilized rt 11mm lo# 65011545 mdr: 3007963827-2022-00237.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  visual examination of the returned product identified signs of use with some damages on the distal surface and bone cement like debris on the augment holes.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were not provided.The complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C
• Common Device Name: 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15402187
• Report Number: 3007963827-2022-00236
• Device Sequence Number: 6217819
• Product Code: JWH
• UDI-Device Identifier: 00889024471023
• UDI-Public: (01)00889024471023(17)320410(10)65321784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006402
• Device Lot Number: 65321784
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Unknown