MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI LM/RL TIB AUG SZ3 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5545-A-301

Device Problems Out-Of-Box Failure (2311); Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

The following device was also listed in this report: tri rm/ll tib aug sz3 10mm; cat#:5546-a-302; lot#:er9hj7.This device was included inside the box that was mislabeled as the primary product in this report.A supplemental report will be submitted upon completion of the investigation.

Event Description

It has been reported that during a right knee surgery, when the surgeon opened the box of the product, that did not match with the item number in the label.The label showed: ref 5545-a-301 lot er9km2d (right).The item in the interior was: 5546-a302 lot er9hj7 (right).Update 22/10/16: there was a delay of 20 mintues.As the surgeon have not any additional product, he finished the procedure by opening a 5543-a- 300 (left implant) and placing this item in the tibial plate with cement.

Manufacturer Narrative

An event regarding a product mix involving a tri lm/rl tib aug sz3 5mm was reported.The event was not confirmed.Method & results: -device evaluation and results: the reported device and packaging was received.The outer box and product labels listed a tibial augment half block (catalog: 5545-a-301, lot: er9km2d).The device is a tibial augment half block (catalog: 5546-a-302, lot: er9hj7).-medical records received and evaluation: not performed as no medical records were provided.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: there have been no other reported events for the lot referenced.Conclusion: an nc was issued for manufacturing investigation of the event.Based upon the nc investigation, at no point were the subjected lots processed on the shop floor at the same time.The nc concluded, "there will be no correction for this nc since this is an isolated event and the investigation demonstrated that it is unlikely that this occurred during manufacturing or packaging." no further investigation for this event is required at this time.

Event Description

It has been reported that during a right knee surgery, when the surgeon opened the box of the product, that did not match with the item number in the label.The label showed: ref 5545-a-301 lot er9km2d (right).The item in the interior was: 5546-a302 lot er9hj7 (right).Update 22/10/16: there was a delay of 20 minutes.As the surgeon have not any additional product, he finished the procedure by opening a 5543-a- 300 (left implant) and placing this item in the tibial plate with cement.

• Brand Name: TRI LM/RL TIB AUG SZ3 5MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6091280
• MDR Text Key: 59871194
• Report Number: 0002249697-2016-03558
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Catalogue Number: 5545-A-301
• Device Lot Number: ER9KM2D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other