MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6519-T-204
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2017
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 that, during a tha, the trunnion sleeve did not fit completely (there was a gap) on the stem trunnion (citation stem).
Additional Manufacturer Narrative
Additional information: returned to manufacturer on; reason for no evaluation; an event regarding a size/fit issue mode involving a v40 sleeve was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the device was visually unremarkable.Dimensional inspection: a dimensional inspection was performed on the returned device.The device is dimensionally within specification.Medical records received and evaluation: not performed as no medical records were provided for review.Device history review: the device was manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: a dimensional inspection was performed on the returned device.All dimensions were found to be within specification.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
It was reported that, during a tha, the trunnion sleeve did not fit completely (there was a gap) on the stem trunnion (citation stem).

• Brand Name: UNI ADAPTOR SLEEVE V40 TI
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6903193
• Report Number: 0002249697-2017-02888
• Device Sequence Number: 19005794
• Product Code: LZO
• UDI-Device Identifier: 04546540608406
• UDI-Public: 04546540608406
• Combination Product (Y/N): N
• PMA/510(K) Number: K070885
• 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): 01/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2021
• Device Catalogue Number: 6519-T-204
• Device Lot Number: 55745304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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