MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROX FEM COM TROCHANTERIC; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64951002

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Upon selection of implant the box was in great shape.When the nurse opened the box the inside packaging was cracked but the inner packaging was still in tact.Surgeon wanted a different implant due to sterility so we opened another implant.The box was in good shape, but the plastic packaging was cracked and so was the inner package.It looks like someone cracked the plastic cartons before putting into stryker box.

Manufacturer Narrative

An event regarding packaging damage involving a gmrs proximal femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing the flange of the outer blister to fracture.-medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling during transportation/storage.No further investigation for this event is required at this time.

Event Description

Upon selection of implant the box was in great shape.When the nurse opened the box the inside packaging was cracked but the inner packaging was still in tact.Surgeon wanted a different implant due to sterility so we opened another implant.The box was in good shape, but the plastic packaging was cracked and so was the inner package.It looks like someone cracked the plastic cartons before putting into stryker box.

Manufacturer Narrative

A second supplemental report is being submitted on 5/1/2017 to include method codes.

Event Description

Upon selection of implant the box was in great shape.When the nurse opened the box the inside packaging was cracked but the inner packaging was still in tact.Surgeon wanted a different implant due to sterility so we opened another implant.The box was in good shape, but the plastic packaging was cracked and so was the inner package.It looks like someone cracked the plastic cartons before putting into stryker box.

• Brand Name: GMRS PROX FEM COM TROCHANTERIC
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5166809
• MDR Text Key: 29216196
• Report Number: 0002249697-2015-03433
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• 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,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 64951002
• Device Lot Number: ECFFX1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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
• Patient Age: 68 YR
• Patient Weight: 114