MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIAL COMPONENT PEGGED PRECOAT FOR CEMENTED USE ONLY SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00575001506 - femoral component precoat size e minus (e-) right - 64545650.00597603010 - articular surface anterior constrained size yellow - 64466517.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00077, 0001822565-2021-00869.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.During the initial procedure, it was noted that the mcl had avulsed from the tibia after placement of all of the final implants.The tear was anchored down with sutures and the procedure completed without further complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: after cementing the final components, the surgeon changed the trial poly to the real poly.During which he noted laxity medially with the real implant and noted the mcl had avulsed from the tibia.Therefore, the surgeon placed two suture anchors and two layers of sutures in the mcl and brought it down nicely to the tibia.It was very stable.No other complication was noted.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
No change in the previously found root cause.However, during the investigation, we found that the surgeon used incompatible implant assembly.Per nexgen knee profiler, the combination of gender solutions cr-flex minus precoat femoral is not compatible with nexgen cr/cra (ac) articular surface.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIAL COMPONENT PEGGED PRECOAT FOR CEMENTED USE ONLY SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11581852
• Report Number: 0002648920-2021-00067
• Device Sequence Number: 14664048
• Product Code: JWH
• UDI-Device Identifier: 00889024214385
• UDI-Public: (01)00889024214385(17)251130(10)63215771
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00597003502
• Device Lot Number: 63215771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 08/10/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/29/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 79