MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-2530
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate 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
During primary hip replacement surgery the surgeon asked for an accolade tmzf 2.5 132 stem, from an undamaged unopened box the implant box was opened per normal, at that time the nurse noticed the outer lid was not sealed and opened, further inspection was given and the inner lid was opened as well making the implant contaminated.
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.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other events for the lot referenced.Conclusions: a capa was raised to investigate the event.The capa concluded inadequate process and controls when required to inspect, identify, disposition, rework, track and reconcile product that is returned from an (b)(4) location.Inadequate identification of product returned from finished goods.Inadequate controls governing the shrink wrapping of product in (b)(4).Recall pr1570495 was issued for this lot.
Event or Problem Description
During primary hip replacement surgery the surgeon asked for an accolade tmzf 2.5 132 stem, from an undamaged unopened box the implant box was opened per normal, at that time the nurse noticed the outer lid was not sealed and opened, further inspection was given and the inner lid was opened as well making the implant contaminated.

• Brand Name: ACCOLADE 132 SIZE 2.5
• 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: 6740735
• Report Number: 0002249697-2017-02276
• Device Sequence Number: 19149392
• Product Code: LPH
• UDI-Device Identifier: 04546540510617
• UDI-Public: 04546540510617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• 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): 10/26/2017

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: 08/09/2021
• Device Catalogue Number: 6020-2530
• Device Lot Number: 55967305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 10/26/2017
• 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
• Patient Age: 56 YR
• Patient Weight: 98