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

Catalog Number 64852608

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7725803
• MDR Text Key: 115365934
• Report Number: 0002249697-2018-02342
• Device Sequence Number: 1
• Product Code: LGE
• UDI-Device Identifier: 07613327048247
• UDI-Public: 07613327048247
• Combination Product (y/n): N
• PMA/PMN Number: K992346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 64852608
• Device Lot Number: LPTC306
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR