MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #1; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5520B100
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a tka, when a nurse opened the blister pack, a surgeon found some white powder on the base plate.A spare was used instead.
Event or Problem Description
It was reported that, during a tka, when a nurse opened the blister pack, a surgeon found some white powder on the base plate.A spare was used instead.
Additional Manufacturer Narrative
An event regarding foreign matter(white powder) involving a triathlon baseplate was reported.The event was confirmed by visual inspection.Conclusion: the packaging cell reviewed the event and stated: a device history record review indicated that baseplate devices were manufactured as part of batch and accepted into final stock.No other complaints have been received for the lot.The device inner blister and packaging were received to limerick for inspection.The packaging blister was opened but re-sealed with adhesive tape.The outer blister was not returned for evaluation.The white residue is consistent to what would be observed when packaging is mishandled during transport and mechanical abrasion occurs between the baseplate and the inner petg blister.The outer blister was not present to evaluate for damage.This particular complaint can potentially be attributed to mechanical abrasion between the baseplate component and the inner blister, possibly due to mishandling during transport outside of stryker control.This type of defect is not related to the manufacturing process or the packaging materials.All packaging materials have been qualified using appropriate ship testing standards.Based on the damaged unit carton and the presence of white powder which is likely attributable to mechanical abrasion between the baseplate component and the inner blister, it appears that this pack was subjected to mishandling during transport/distribution.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 PRIM CEM FXD BPLT #1
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7587788
• Report Number: 0002249697-2018-01757
• Device Sequence Number: 19132942
• Product Code: MBH
• UDI-Device Identifier: 07613327041040
• UDI-Public: 07613327041040
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 05/31/2022
• Device Catalogue Number: 5520B100
• Device Lot Number: CEA9N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 77 YR
• Patient Weight: 55