MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HMRS CONSTRUCT; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_LIM

Device Problem Component Missing (2306)

Patient Problem Injury (2348)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This pi is for the revision of an hmrs construct.As reported: hmrs revision.During the procedure it was recognized that the correct implants were missing.There were implants for the fixed hmrs but not for the rotating hmrs.Update 19/july/2019 wg: as reported in adverse consequences details: surgery could not be completed successfully.Surgical delay of 20 minutes not longer.Revision took place on (b)(6) 2019 and has been completed successfully.

Manufacturer Narrative

Additional information: patient information an event regarding wear and instability involving an unknown hmrs bushing was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned. clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided or reports confirm the reported event of the intraoperative event of product not being available for surgery.Need operative reports, office/clinical reports, serial x-rays, patient demographics, date and nature of initial procedure.-device history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification and return, operative reports, office/clinical reports, serial x-rays, patient demographics, date and nature of initial procedure.Are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for the revision of an hmrs construct.As reported: hmrs revision.During the procedure it was recognized that the correct implants were missing.There were implants for the fixed hmrs but not for the rotating hmrs.Update 19/july/2019 wg: as reported in adverse consequences details: surgery could not be completed successfully.Surgical delay of 20 minutes not longer.Revision took place on (b)(6) 2019 and has been completed successfully.

• Brand Name: UNKNOWN HMRS CONSTRUCT
• 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: 8890765
• MDR Text Key: 154331590
• Report Number: 0002249697-2019-02832
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR