MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 53MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-653
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that packs were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Product was used.
Event or Problem Description
It was reported that, during a bipolar hip arthroplasty, when the nurse opened the outer blister pack, our sales representative found a unsealed lid of inner blister.The centrax was used as is.
Event or Problem Description
It was reported that, during a bipolar hip arthroplasty, when the nurse opened the outer blister pack, our sales representative found a unsealed lid of inner blister.The centrax was used as is.
Additional Manufacturer Narrative
An event regarding packaging issue involving an other hip liner was reported.The event was not confirmed.Conclusions: although an image was provided showing the inner foil and blister not sealed, the event could not be confirmed as the packaging was not returned for further evaluation.Nc/capa was issued for an unsealed foil on inner blister.It was determined that the scope can be restricted to this one piece based on the 100% verification of product after the inner and outer blister sealing operation and the passing in-process testing results.No further investigation for this event is possible at this time.If device and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CENTRAX DURATION 26MM X 53MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7325176
• Report Number: 0002249697-2018-00676
• Device Sequence Number: 109919
• Product Code: JDI
• UDI-Device Identifier: 07613327032260
• UDI-Public: 07613327032260
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 6226-2-653
• Device Lot Number: 9235AK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other