MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 17X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64853117

Device Problems Device Damaged Prior to Use (2284); Device Packaging Compromised (2916); Material Integrity Problem (2978); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

While doing a distal femoral replacement and opening implants, the surgeon and scrub tech noticed that the implant package looked to have been tampered with and the implant itself looked to have been used (nicked) and possibly resterilized.They were not comfortable using said implant.We washed these implants and opened up and used another stem.

Manufacturer Narrative

An event regarding packaging damage involving an mrs stem component was reported.The event was confirmed.Method & results: -device evaluation and results: based on the damage observed it appears that the pack was possibly dropped and compressed to cause the damage observed.-medical records received and evaluation: not performed as the event is related to a packaging issue.-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: the investigation concluded that the packaging damage was caused by excessive/inappropriate handling.No further investigation for this event is possible at this time.

Event Description

While doing a distal femoral replacement and opening implants, the surgeon and scrub tech noticed that the implant package looked to have been tampered with and the implant itself looked to have been used (nicked) and possibly resterilized.They were not comfortable using said implant.We washed these implants and opened up and used another stem.

• Brand Name: MRS FEM STEM W/O BODY 17X127MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5878300
• MDR Text Key: 52202832
• Report Number: 0002249697-2016-02611
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 64853117
• Device Lot Number: 118249C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2013
• 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: 75 YR
• Patient Weight: 125