MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5520-B-600
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
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 reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The surgeon opened the sterile package containing the triathlon tibial component and noticed, while still in the plastic tray, that there was a small amount of very fine debris on the component.He was unhappy to use the component and asked for another one.He then noticed the second component also had the same small fine debris on it.It was a different batch number.This time he washed the component with betadine and implanted it.It was noticed as the surgeon opened the sterile packaging, but had not yet picked the component up.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon baseplate was reported.The event was confirmed by visual inspection.Device evaluation and results:the inner blister without its tyvek lid was returned in a biohazard bag.One baseplate was returned in the inner blister for analysis.There is evidence of scuffing on the inner blister.The inferior surface of the baseplate has white debris on the keel.No outer blister or unit carton was returned for analysis.Medical records received and evaluation: not performed as the event relates to a packaging issue.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events reported for the lot referenced.The material analysis report (mar) indicated that characterisation of baseplate component confirmed white particles on the tip of the keel area.Characterisation using stero microscopy and infrared spectroscopy confirmed particles as debris from petg inner blister tray.Particles potential originated from mechanical abrasion between baseplate component and inner blister tray.The exact cause of the event could not be determined because insufficient information was provided.Further information such as all packaging return including the outer blister and unit carton is required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The surgeon opened the sterile package containing the triathlon tibial component and noticed, while still in the plastic tray, that there was a small amount of very fine debris on the component.He was unhappy to use the component and asked for another one.He then noticed the second component also had the same small fine debris on it.It was a different batch number.This time he washed the component with betadine and implanted it.It was noticed as the surgeon opened the sterile packaging, but had not yet picked the component up.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 6778732
• Report Number: 0002249697-2017-02429
• Device Sequence Number: 13682910
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: 07613327050349
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 10/26/2017

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: 03/27/2022
• Device Catalogue Number: 5520-B-600
• Device Lot Number: B222R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/26/2017
• 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: 67 YR
• Patient Weight: 91