MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIB SML; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64953101
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.
Event or Problem Description
A representative from the hospital reported the following event : " the external packaging of the implant is defective.When opened, the plastic part broke and remained stuck to tyvek.The primary packaging of the implant is intact.The implant could thus be square.
Additional Manufacturer Narrative
An event regarding packaging damage involving a gmrs tibial component was reported.The event was confirmed by evaluation of the returned packaging.Method & results: device evaluation and results: visual inspection of the returned packaging indicates that there are clear indentation lines are visible on the top of the carton box near the opening end on the inside and the outside.The outer blister was returned with the tyvek lid removed.One side flange/lip of the outer blister was broken off the outer blister and remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.The body of the blister is also severely cracked.The device and the inner blister was not returned- it is reported that as there was a good seal on inner blister, the device was implanted.Medical records received and evaluation: not performed as the event is related to a packaging issue and medical records were not provided for this event.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 lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening of the packaging whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton.No further investigation for this event is required at this time.
Event or Problem Description
A representative from the hospital reported the following event : " the external packaging of the implant is defective.When opened, the plastic part broke and remained stuck to tyvek.The primary packaging of the implant is intact.The implant could thus be square.

• Brand Name: GMRS PROXIMAL TIB SML
• 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: 8293046
• Report Number: 0002249697-2019-00410
• Device Sequence Number: 1734608
• Product Code: KRO
• UDI-Device Identifier: 07613327048919
• UDI-Public: 07613327048919
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: 09/30/2022
• Device Catalogue Number: 64953101
• Device Lot Number: 092421D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/13/2019
• 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