MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5521-B-300
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right tka.It was reported that when the outer blister of the tibial baseplate was opened, the tyvek of the inner blister was observed to be already opened (not sealed all the way around).Due to sterility concerns, the device was not used.Another device was immediately available in the operating room.Rep confirmed that surgery was completed successfully with no delay, and that no further information is available.
Event or Problem Description
Primary procedure, right tka.It was reported that when the outer blister of the tibial baseplate was opened, the tyvek of the inner blister was observed to be already opened (not sealed all the way around).Due to sterility concerns, the device was not used.Another device was immediately available in the o.R.Rep confirmed that surgery was completed successfully with no delay and that no further information is available.
Additional Manufacturer Narrative
Reported as serious injury in error.An event regarding a packaging issue involving a triathlon baseplate was reported.The event was confirmed upon visual inspection of the device returned.Method & results: device evaluation and results: device arrived without carton and outer tyvek lid.Inner tyvek lid has a discontinuity in one corner of the inner blister seal.Inner tyvek lid also has a crease line, indicating that it has been folded back at this corner.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.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If the secondary packaging and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRI TS BASEPLATE SIZE 3
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8767502
• Report Number: 0002249697-2019-02532
• Device Sequence Number: 1690657
• Product Code: MBH
• UDI-Device Identifier: 07613327026313
• UDI-Public: 07613327026313
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 12/18/2019

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: 01/31/2024
• Device Catalogue Number: 5521-B-300
• Device Lot Number: B943SA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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: 58 YR