MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	5510F601
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left knee.It was reported that the top of the tray of the inner sterile blister was cracked.Surgeon elected to not use the implant due to sterility concerns.Another implant was obtained with a surgical delay of less than a minute while a tourniquet was in use.
Event or Problem Description
Primary procedure, left knee.It was reported that the top of the tray of the inner sterile blister was cracked.Surgeon elected to not use the implant due to sterility concerns.Another implant was obtained with a surgical delay of less than a minute while a tourniquet was in use.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed based on evaluation of the returned packaging.Method & results: -device evaluation and results: the outer blister was returned with the tyvek lid removed on three sides (one side remains sealed).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 device was returned inside the outer blister, it appears unremarkable.The inner blister and outer carton were not returned.-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: 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 reported event indicated the packaging was noted to be damaged upon opening.The outer blister was returned with the tyvek lid removed on three sides (one side remains sealed).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 device was returned inside the outer blister, it appears unremarkable.The inner blister and outer carton were not returned.Without evaluation of the pack carton it is not possible to determine the cause of the reported pack damage, however it appears that this pack was subjected to excessive handling/a shock event to cause the damage noted.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: TRIATHLON CR FEM COMP #6 L-CEM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8253504
• Report Number: 0002249697-2019-00211
• Device Sequence Number: 19380544
• Product Code: JWH
• UDI-Device Identifier: 07613327040319
• UDI-Public: 07613327040319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• 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): 04/18/2019

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: 06/30/2023
• Device Catalogue Number: 5510F601
• Device Lot Number: D4E7E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: 71 YR