MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FIX. PEG 2 PER PK; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5575X000
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that upon opening the implant, 2 small plastic fragments were in the inner packaging.Rep reported that it appeared to be the same type of plastic that the packaging consisted of.Surgeon elected to implant the device, the packaging is available for return.
Event or Problem Description
Primary procedure, right knee.It was reported that upon opening the implant, 2 small plastic fragments were in the inner packaging.Rep reported that it appeared to be the same type of plastic that the packaging consisted of.Surgeon elected to implant the device, the packaging is available for return.
Additional Manufacturer Narrative
An event regarding plastic fragment in the blister involving a triathlon fixation peg pack was reported.The event was confirmed by visual inspection.Conclusion: the complaint product was returned and reviewed using microscopic and ftir analysis methods.The pieces of plastic were confirmed as petg.The inner and outer blister pack are made from petg, along with the retainer tray that sits on top of the inner blister under the tyvek lid.No issues were noted during manufacture and all parts met the 100% visual inspection criteria during the blister pack process and the final pack process.There is no evidence that the plastic matter was on the blister seal area when the tyvek lid was sealed to the blister.There was no evidence of adherence or entrapment in the seal area under microscopic analysis.The retainer tray was not returned as part of the complaint pack, therefore, this cannot be ruled out as the source of the excess plastic.The inner and outer blister were fully intact, and could not have been the source of the material.The root cause cannot be determined at this time without the presence of the retainer tray.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 FIX. PEG 2 PER PK
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7270993
• Report Number: 0002249697-2018-00418
• Device Sequence Number: 1801889
• Product Code: MBH
• UDI-Device Identifier: 07613327050011
• UDI-Public: 07613327050011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 09/30/2022
• Device Catalogue Number: 5575X000
• Device Lot Number: C2J3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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: 74 YR