MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL FEM COMP STD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64951001
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that in revising patient's right hip, rep discovered that the inner packaging of the intended implant was compromised.The outer box and outer packaging were reported to be intact and in good condition.Surgeon elected to not use the implant due to sterility concerns and instead revised patient to a proximal femoral device with a trochanter.As this implant is larger than the intended implant, surgeon reported difficulty in closing the wound as a soft tissue envelope had formed around the original implant.Rep reported a surgical delay of approximately 3 minutes.
Event or Problem Description
It was reported that in revising patient's right hip, rep discovered that the inner packaging of the intended implant was compromised.The outer box and outer packaging were reported to be intact and in good condition.Surgeon elected to not use the implant due to sterility concerns and instead revised patient to a proximal femoral device with a trochanter.As this implant is larger than the intended implant, surgeon reported difficulty in closing the wound as a soft tissue envelope had formed around the original implant.Rep reported a surgical delay of approximately 3 minutes.
Additional Manufacturer Narrative
Corrected data: product not returned.Product available to stryker.An event regarding packaging damage involving a gmrs femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as the event is related to a packaging issue.-device history review: indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: as no product was returned or no photographs provided the reported event could not be confirmed.Further information such as all packaging return including the outer blister and unit carton is 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.

• Brand Name: PROXIMAL FEM COMP STD
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7014248
• Report Number: 0002249697-2017-03259
• Device Sequence Number: 126726
• Product Code: KRO
• UDI-Device Identifier: 07613327048704
• UDI-Public: 07613327048704
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• 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): 01/10/2018

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: 01/12/2022
• Device Catalogue Number: 64951001
• Device Lot Number: BHP9R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: 23 YR