MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID32 OD60; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	63093260
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Material Distortion (2977)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The hospital could not open the package in a sterile way.The paper that you tear away to open the package was stuck in the plastic that surrounds the implant.
Additional Manufacturer Narrative
Additional information: returned to manufacturer on.An event regarding difficulty opening packaging in a sterile manner involving an exeter liner was reported.The event was confirmed by visual inspection.One unit carton without its shrink wrap was returned for evaluation.There is a severe indentation line on the front of the unit carton.Compression is visible on the corner of the unit carton.The outer blister was returned with the tyvek lid opened on three sides.There is evidence of a good seal on the outer blister.On one side of the outer blister some interwoven layers of the tyvek lid have separated from the lid and are still attached to the blister side flange.Correspondingly, there is evidence of partial separation of tyvek material on the inside of the tyvek lid, however the tyvek lid remains intact as a single sheet.The inner blister was returned unopened.For the purpose of this investigation the tyvek lid was removed.There is evidence of a good seal on the inner blister.The returned device appears unremarkable.Medical records received and evaluation: not performed as no medical records were provided.Indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other similar events for the reported lot referenced.The investigation concluded that the component packaging was subjected to excessive/inappropriate handling most likely during transportation/storage of the device.The severe damage to the opening end of the package corresponds to where the damage to the tyvek lid is located.From the returned product it appears that the damage to the outer carton is responsible for the difficulty in opening the blister/plastic surround of the implant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The hospital could not open the package in a sterile way.The paper that you tear away to open the package was stuck in the plastic that surrounds the implant.

• Brand Name: EXETER X3 RIMFIT ID32 OD60
• 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: 6909701
• Report Number: 0002249697-2017-02896
• Device Sequence Number: 13631167
• Product Code: JDI
• UDI-Device Identifier: 07613327072273
• UDI-Public: 07613327072273
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K111848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 01/15/2021
• Device Catalogue Number: 63093260
• Device Lot Number: LEU772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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