MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS XS SHT SPDL W PINS 800LBF; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: compress/oss 5cm tpr adapt w/oss sc catalog#: 178711 lot#: 65766806 compress centering sleeve 14mm catalog#: 178536 lot#: 396780 compress short anchor plug 12mm catalog#: 178554 lot#: 201390 compress transverse pin 6pk 32mm catalog#: 178527 lot#: 501730 compress short anchor plug 12mm catalog#: 178554 lot#: 65889607 compress transverse pin 6pk 36mm catalog#: 178528 lot#: 562900 compress nut co-cr-mo alloy catalog#: 178512 lot#: 65753467 oss rs axle catalog#: 161035 lot#: 65816757 oss poly tibial bushing catalog#: 150476 lot#: 299680 oss reinforced yoke catalog#: 150493 lot#: 65985059 oss poly lock pin catalog#: 150478 lot#: 65734013 oss rs poly fem bushings set/2 catalog#: 161034 lot#: 65795550 oss rs 12mm ls tibial bearing catalog#: 161094 lot#: 66043842 oss por straight stem 10.5x150 catalog#: 150448 lot#: 905350 oss mod tib baseplate 67mm catalog#: 150421 lot#: 65922750 oss segmental stacking adapter catalog#: 150483 lot#: 65904622 oss 5cm diaphyseal segment catalog#: 150465 lot#: 705810 oss rs 7 cm mod seg fmrl-rt catalog#: 161011 lot#: 612060 tibial perimeter cone right size large catalog#: 42545001523 lot#: 64627887 tibial central cone size large catalog#: 42545000513 lot#: 65076064 customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately seven months post-implantation due to an unknown failure of the compress prosthesis.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, g6, h2, h6, and h11.
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately seven months post-implantation due to an unknown failure of the compress prosthesis possibly due to a spindle of inappropriate diameter.The surgeon wanted to use a different diameter spindle at the time of initial implantation, but none were available.
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.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: distal femoral resection with what appears to be a hinged prosthesis right total knee arthroplasty.Possible hardware failure at the junction of the proximal hardware in the femoral stem which demonstrates slight angulation.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: COMPRESS XS SHT SPDL W PINS 800LBF
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19097884
• Report Number: 0001825034-2024-01007
• Device Sequence Number: 7343963
• Product Code: KRO
• UDI-Device Identifier: 00880304509115
• UDI-Public: (01)00880304509115(17)290831(10)625580
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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 Model Number: N/A
• Device Catalogue Number: 178364
• Device Lot Number: 625580
• Was Device Available for Evaluation?: No
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 09/26/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 09/24/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2019
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown