MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Concomitant medical products: 00596404210, articular surface, lot # 63455949, 00596401751, femoral component, lot # 62209547.Report source: event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00451.
Event or Problem Description
It was reported that approximately 3.5 years post implantation, the patient was revised of the tibial components due to pain, instability and fractured tibial tray.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
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.Visual examination of the returned tibial tray found it exhibits signs of being implanted and is fractured.Examination of the returned articular surface found it exhibits signs of being implanted and shows extreme wear due to the tibial implant fracture.Device was submitted for further analysis.Analysis determined fracture surface artifacts of beach marks indicate the fatigue failure mode, while the presence of a bending hinge suggests final bending overload fracture.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-rays previously reviewed by the surgeon were provided.Review found tibial subsidence and implant fracture.Images were not sent for further review as it would not enhance the investigation.It was reported that the patient continued to go jogging when advised not to.As stated in the instructions for use, complications and/or failure of prosthetic implants are more likely to occur in physically active patients.The root cause of the reported event is attributed to patient failing to follow manufacturer and medical post-op instructions.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: STEMMED TIBIAL COMPONENT PRECOAT SIZE 5
• 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: 9661058
• Report Number: 0002648920-2020-00064
• Device Sequence Number: 11676121
• Product Code: JWH
• UDI-Device Identifier: 00889024217607
• UDI-Public: (01)00889024217607
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598004701
• Device Lot Number: 63413442
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 05/19/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 05/13/2020; 05/20/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention