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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding foreign matter (white flecks) present on a gmrs proximal femoral component and its packaging was reported.The event was confirmed based on photographs provided.Method & results: -device evaluation and results: the reported device and packaging were not returned however photographs were provided for review.The photographs show a gmrs proximal femur and some of its packaging.There are white flecks visible on the device and on the inner blister packaging.There is a concentration of white flecks/powder around the anti-rotation tabs of the femoral component and on the taper.Three photographs of the outer carton were provided with nothing remarkable to note.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the reported device and packaging were not returned however photographs were provided for review.The photographs show a gmrs proximal femur and its packaging.There are white flecks visible on the device and on the inner blister packaging.There is a concentration of white flecks/powder around the anti-rotation tabs of the femoral component and on the taper.Three photographs of the outer carton were provided with nothing remarkable to note.It is possible that the foreign matter (white flecks) are as a result of scuffing or vibration and mechanical abrasion of the device within its inner blister pack, however this cannot be confirmed without analysis of the foreign matter.Additional information including return of the device and packaging and analysis of alleged foreign matter are needed to fully investigate the event.If further information becomes available or the product packaging is returned, this investigation will be re-opened.
Event or Problem Description
This pi is for the intra-operative event.It was reported that while performing a revision on the patient's right hip, a gmrs proximal femoral standard component was opened and observed to have white flecks on it.The implant itself appeared to have damage to it.Rep reported the packaging did not appear to have any damage.A gmrs proximal femoral trochanteric device was immediately available in the o.R.And used to complete the case with no surgical delay.Rep provided pictures of the device and packaging and reported that no further information will be available.

• 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: 9305883
• Report Number: 0002249697-2019-03728
• Device Sequence Number: 14002172
• Product Code: LPH
• UDI-Device Identifier: 07613327048735
• UDI-Public: 07613327048735
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 11/11/2019

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: 01/31/2022
• Device Catalogue Number: 64951201
• Device Lot Number: BDJ3S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/11/2019
• 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
• Patient Age: 61 YR