MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JOINT REPLACEMENT_PRODUCT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 05/28/2020

Event Type  Injury  

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.Device not returned.

Event Description

It was reported that the patient's right knee was revised due to being "grossly unstable" (reported by surgeon).The patient's cr knee was revised.Rep confirmed that no further information will be released by the hospital or surgeon.

Event Description

It was reported that the patient's right knee was revised due to being "grossly unstable" (reported by surgeon).The patient's cr knee was revised.Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Update the conclusion code.Reported event: an event regarding revision due to instability involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as the device lot code was not provided.Complaint history review: could not be performed as the device lot code was not provided.Conclusions: it was reported that the patient's right knee was revised due to being "grossly unstable" (reported by surgeon).The event can not be confirmed nor the exact cause be determined because insufficient information was available with stryker.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Device not returned.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_PRODUCT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10161593
• MDR Text Key: 195369920
• Report Number: 0002249697-2020-01208
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR