MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROX FEM STANDARD RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	64951201
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
Company rep reported that during trialing the implant and trial did not match.Surgeon opened another implant and completed surgery successfully.
Additional Manufacturer Narrative
An event regarding incorrect selection involving a gmrs proximal femoral component was reported.The event was confirmed.Device evaluation and results:the gmrs prox fem standard right was returned for evaluation.The device was inspected against its product drawing and it was confirmed to be a right proximal femoral component as per product identification.The returned device appears unremarkable.Medical records received and evaluation: x-rays were provided in relation to cross reference pi only.No medical records were provided in relation to the reported event regarding incorrect selection of the gmrs proximal femoral component.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot referenced.Conclusions: the x-rays provided were of a left knee with femur and hip.The patient labels provided of the devices for implantation confirms that the connection piece was for a left side.The gmrs proximal femoral component the surgeon tried to implant was for a right side.Using the right proximal femoral would dictate the orientation of the component and thus rotate the femur into internal rotation.Based on the information provided it appears that the gmrs right proximal femoral component was wrongly selected for use on a left side.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 or Problem Description
Company rep reported that during trailing the implant and trial did not match.Surgeon opened another implant and completed surgery successfully.The surgeon stated that the trials had rotated the femur into external rotation but the real implant had pushed it into internal rotation.

• Brand Name: GMRS PROX FEM STANDARD RIGHT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6679674
• Report Number: 0002249697-2017-02085
• Device Sequence Number: 13718932
• Product Code: LPH
• UDI-Device Identifier: 07613327048735
• UDI-Public: 07613327048735
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2021
• Device Catalogue Number: 64951201
• Device Lot Number: ATT4H1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 10/24/2017
• 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: Other