MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK TIBIAL BASEPLATE-LM/RL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Mako baseplate was revised and was broken in 2 pieces.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 300 devices were manufactured and accepted into final stock on 17-jun-2019 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the baseplate was broken in 2 pieces.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Mako baseplate was revised and was broken in 2 pieces.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 4
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10992246
• Report Number: 3005985723-2020-00385
• Device Sequence Number: 19026954
• Product Code: NPJ
• UDI-Device Identifier: 00848486000707
• UDI-Public: 00848486000707
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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 Model Number: 180604
• Device Catalogue Number: 180604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR