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 Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a primary implant of the accolade ii 132 angle stem, both outer and inner packaging were found to be compromised.Surgeon used a 127 angle stem instead.Surgical delay was reported to be under 5 minutes with no adverse affects to the patient.
Additional Manufacturer Narrative
An event regarding a packaging issue with a accolade stem was reported.The event was confirmed.Device evaluation and results: the device was visually inspected on return.Both the inner and outer tyvek lid were found to be peeled back and open as reported in the event description.Medical records received and evaluation: no medical records were received for review with a clinical consultant.No adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: nc has been raised to investigate the event.Capa investigation was completed and the following root causes were determined: the primary root-cause for occurrence is "inadequate process and controls when required to inspect, identify, disposition, rework, track and reconcile product that is returned from an fg location".The primary root-cause for escape is "no requirement to have an active halt on lots which are returned from finished goods, or which are transferred into the prms nc warehouse".
Event or Problem Description
It was reported that during a primary implant of the accolade ii 132 angle stem, both outer and inner packaging were found to be compromised.Surgeon used a 127 angle stem instead.Surgical delay was reported to be under 5 minutes with no adverse affects to the patient.

• 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: 6759733
• Report Number: 0002249697-2017-02354
• Device Sequence Number: 16574779
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: 04546540664518
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2021
• Device Catalogue Number: 6720-0837
• Device Lot Number: 56211401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 10/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-07/25/2017-004R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR