MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0837
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported on the implant, looks like frizzy white cotton like material.It was reported they decided not to implant and allegedly kept implant and original box.
Additional Manufacturer Narrative
An event regarding foreign material involving a accolade stem was reported.The event was confirmed.Method and results: -device evaluation and results: a visual inspection of the returned device was carried out.This noted a fibre like material on the ha coating of the device.The device was otherwise unremarkable.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other events for the reported lot.Conclusions: (b)(4) has been raised to investigate the event.(b)(4) was raised on 23-feb-2017 and closed on 31-mar-2017.The scope and corrective actions are detailed within the nc and corresponding (b)(4).(b)(4) determined the fiber was most likely introduced to the accolade ii stem in the ha coating and packaging business units.
Event or Problem Description
It was reported on the implant, looks like frizzy white cotton like material.It was reported they decided not to implant and allegedly kept implant and original box.

• Brand Name: SIZE 8 ACCOLADE II 132 DEG
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6307144
• Report Number: 0002249697-2017-00475
• Device Sequence Number: 768896
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: (01)04546540664518(11)160222(17)210228(10)54727401
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• 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): 04/13/2017

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: 02/28/2021
• Device Catalogue Number: 6720-0837
• Device Lot Number: 54727401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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