MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number 6721-0435

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.

Event Description

It was reported that, during a tha, when a nurse opened the outer blister pack, a surgeon found a hair on the inner blister pack.A spare (same size) was used.

Event Description

It was reported that, during a tha, when a nurse opened the outer blister pack, a surgeon found a hair on the inner blister pack.A spare (same size) was used.

Manufacturer Narrative

An event regarding foreign matter involving an accolade stem was reported.The event was confirmed.Dimensional inspection: not performed as the reported event is not related to the dimensional integrity of the device.Functional inspection: not performed as the reported event is not related to the device function.Material analysis: not performed as reported event is not related to the material integrity of the device.-medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be confirmed.As the device was returned opened it cannot be confirmed where the hair came from.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

• Brand Name: SIZE 4 ACCOLADE II 127 DEG
• Type of Device: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7655717
• MDR Text Key: 112997323
• Report Number: 0002249697-2018-02015
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669490
• UDI-Public: 04546540669490
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 6721-0435
• Device Lot Number: 63977201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other