MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS BEADED TIBIAL STEM 9MM; IMPLANT

Catalog Number 64856409

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/25/2014

Event Type  malfunction  

Event Description

It was reported that during primary right knee surgery, the inner package of the implant was open.So sterility of the implant was compromised.Surgeon used a different implant and completed the surgery with 15 minutes delay.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The patient is (b)(6) inches in height.An event regarding packaging damage involving an mrs stem component was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned stem, outer blister and inner blister was performed.The outer blister tyvek lid has a dishevelled appearance but otherwise there is nothing of note in relation to the outer blister pack.The inner blister has some evidence of mishandling however without inspection of the outer carton, it is not possible to definitively determine the cause of the damage on the inner blister pack.The device appears normal with no discrepancies noted.There is evidence of some contamination on the inner tyvek lid, which may be blood.The packaging and device will be discarded as a result.Device history review: dhr review determined that the lot was manufactured and packed to specification.Complaint history review: chr review determined that there were no similar events reported for the lot.Conclusions: no further investigation for this event is possible as the outer carton was not received for inspection by stryker orthopaedics.Inspection of this packaging would be required to determine how the damage observed on the inner blister occurred.

Event Description

It was reported that during primary right knee surgery, the inner package of the implant was open.So sterility of the implant was compromised.Surgeon used a different implant and completed the surgery with 15 minutes delay.

• Brand Name: MRS BEADED TIBIAL STEM 9MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4081257
• MDR Text Key: 4827254
• Report Number: 0002249697-2014-03459
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 64856409
• Device Lot Number: TEC1098
• Other Device ID Number: STER. LOT L3105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2010
• 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
• Patient Age: 63 YR
• Patient Weight: 79