MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK PATELLOFEMORAL-L-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180404

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.The following devices were also listed in this report: patellar component; unk_ofl; unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

It was reported that the patient's left knee was revised.Initial patient complaint was pain, surgeon reported that there are no allegations against the implants and that progression of the patient's existing disease, causing the knee to collapse into valgus.A patellofemoral implant and patellar component were revised.Rep confirmed that no further information will be released.

Manufacturer Narrative

Reported event: an event regarding patient factors involving a mako patella was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: no medical records were received for review with a clinical consultant.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.

Event Description

It was reported that the patient's left knee was revised.Initial patient complaint was pain, surgeon reported that there are no allegations against the implants and that progression of the patient's existing disease, causing the knee to collapse into valgus.A patellofemoral implant and patellar component were revised.Rep confirmed that no further information will be released.

• Brand Name: MCK PATELLOFEMORAL-L-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10390468
• MDR Text Key: 202364527
• Report Number: 3005985723-2020-00247
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000424
• UDI-Public: 00848486000424
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 180404
• Device Catalogue Number: 180404
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 111