MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; IMPLANT

Catalog Number 5510F502

Device Problems Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Upon opening a sealed implant box, the scrub tech noticed the interior blister pack was compromised.The implant was set to the side and another implant was used.

Manufacturer Narrative

An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: based on the review by the packaging engineering department the inner blister the pack may only become damaged if the pack was dropped either prior to outer blister packaging by the packaging operator, or upon opening in the or by theatre staff.On review of the process in the metals clean room the only way this damage could have occurred would be if the skin pack was dropped.However the skin pack would be inspected per (b)(4) " procedure for evaluation of sterile barrier system seal integrity." and if any discrepancy was noted the part would be re skin packed.In the or, it is common practice to 'drop' the inner pack from the outer pack, onto the sterile prep table.It is possible that the inner pack became damaged if it was accidently dropped onto a device (instrument,tray, etc.)already on the sterile prep table.As stated, there are two possible causes of this occurrence, but neither are conclusive.-medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: there have been no other events for the lot referenced.Conclusions: based on the review by the packaging engineering department, there are two possible causes of this occurrence, the inner blister was dropped either prior to outer blister packaging by the packaging operator, or upon opening in the or by theatre staff.Neither are conclusive.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Upon opening a sealed implant box, the scrub tech noticed the interior blister pack was compromised.The implant was set to the side and another implant was used.

• Brand Name: TRIATHLON CR FEM COMP #5 R-CEM
• 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: 4965589
• MDR Text Key: 23526341
• Report Number: 0002249697-2015-02555
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 5510F502
• Device Lot Number: EMKNB
• Other Device ID Number: STERILE LOT: T1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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