MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 14MM; PROSTHESIS, KNEE

Model Number	150411
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown cemented femoral stem: catalog#ni, lot#ni; unknown cement: catalog#ni, lot#ni; unknown femoral component: catalog#ni, lot#ni; unknown hinge assembly: catalog#ni, lot#ni; unknown tibial tray and stem: catalog#ni, lot#ni.Report source: foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02783, 0001825034-2021-02784.
Event or Problem Description
It was reported that patient underwent a total knee arthroplasty and experienced post-operative complications approximately 1 year and 9 months post implantation.At that time patient was revised due to loosening of the femoral cemented stem as well as wear and fracture of the polyethylene.Attempts were made and no further information was provided.
Event or Problem Description
It was reported that patient underwent a total knee arthroplasty and experienced post-operative complications approximately 2 year and 8 months post implantation.At that time patient was revised due to loosening of the femoral cemented stem as well as wear and fracture of the polyethylene.Attempts were made and no further information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: oss cemented im stem 18x150 50: catalog#150372, lot#216090; optipac 80 refob bone cmt r-3: catalog#47125003983, lot#812aa09210; unknown femoral component: catalog#ni, lot#ni; unknown hinge assembly: catalog#ni, lot#ni; unknown tibial tray and stem: catalog#ni, lot#ni.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A2: the patient was born in 1949.D10: medical product: oss cemented im stem 18x150 50: catalog#:150372, lot#:216090; optipac 80 refob bone cmt r-3: catalog#:4712500398-3, lot#812aa09210; oss rs 7 cm mod seg fmrl-lt: catalog#:161012, lot#:906620; oss 3cm ellip diaphyseal seg: catalog#:150461, lot#:658110; oss rs poly fem bushings set/2: catalog#:161034, lot#:998490; oss rs axle: catalog#:161035, lot#559330; oss mod tib baseplate 67mm: catalog#:150421, lot#:947160; oss cemented im stem 13mmx90mm: catalog#:150362, lot#:415430; oss poly tibial bushing: catalog#:150476, lot#:315060.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned item found it to exhibit signs of being implanted scratched / gouged / worn and foreign material imbedded.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap film of the left knee demonstrates a left total knee arthroplasty with hinged prosthesis and long stem femoral component status post distal femoral resection.Possible loosening at the bone cement interface of the femoral component.No fracture seen.Root cause was unable to 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 at time of this report.

• Brand Name: OSS TIBIAL POLY BEARING 14MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12555764
• Report Number: 0001825034-2021-02782
• Device Sequence Number: 17289092
• Product Code: JDI
• UDI-Device Identifier: 00880304010888
• UDI-Public: (01)00880304010888(17)230207(10)822750
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2022

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: 02/07/2023
• Device Model Number: 150411
• Device Catalogue Number: 150411
• Device Lot Number: 822750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 11/04/2021; 01/31/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/21/2021; 11/24/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 100 KG