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

Catalog Number 64951201

Device Problems Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2017

Event Type  malfunction  

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 Description

Company rep reported that during trialing the implant and trial did not match.Surgeon opened another implant and completed surgery successfully.

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 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6679674
• MDR Text Key: 78907842
• Report Number: 0002249697-2017-02085
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327048735
• UDI-Public: 07613327048735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other