MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 8MM PT2 ALLPOLY TIB KRH XXSML; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING

Catalog Number	64852608
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that after trialing, components were cemented in when it was discovered that the implants were much longer than the trials (trials and implants were matched).A surgical delay of 1 hour was caused by the need to explant all devices and re-implant devices which fit the patient.No tourniquet was used.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a krh tibial component was reported.The event was not confirmed.Conclusions: it was reported that during patients right knee surgery, after trialing, components were cemented in when it was discovered that the implants were much longer than the trials (trials and implants were matched).A surgical delay of 1 hour was noted.Visual inspection of the received image of the device noted that the device was covered with stains of blood.The event was not confirmed neither the root cause could be determined since insufficient information was available.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, right knee.It was reported that after trailing, components were cemented in when it was discovered that the implants were much longer than the trials (trials and implants were matched).A surgical delay of 1 hour was caused by the need to explant all devices and re-implant devices which fit the patient.No tourniquet was used.

• Brand Name: 8MM PT2 ALLPOLY TIB KRH XXSML
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7725803
• Report Number: 0002249697-2018-02342
• Device Sequence Number: 13679077
• Product Code: LGE
• UDI-Device Identifier: 07613327048247
• UDI-Public: 07613327048247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992346
• 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): 09/25/2018

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: 01/31/2022
• Device Catalogue Number: 64852608
• Device Lot Number: LPTC306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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: 13 YR