MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE -3MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	6942-7-060
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It was reported that during a primary hemi hip arthroplasty (side not provided) the unipolar head and sleeve would not engage on the stem.
Additional Manufacturer Narrative
An event regarding an assembly issue involving a sleeve was reported.The event was confirmed.Device evaluation and results: the device was returned in good condition and was lodged in the taper of the head.Review of the device by a material analysis engineer indicated, "damage consistent with attempted assembly was observed on the head and sleeve." dimensional inspection confirmed the device was within specifications.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusion: the event is confirmed however the root cause could not be determined as the stem was not returned.It is possible that there was improper order of assembly (i.E.Surgical protocol deviation) which could have caused the mating devices to not assemble.Surgical protocol indicates the sleeve should be assembled on the taper of the stem and then the head can be impacted on the sleeve.It seems the sleeve was placed in the head and then impacted onto the taper of the stem.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that during a primary hemi hip arthroplasty (side not provided) the unipolar head and sleeve would not engage on the stem.

• Brand Name: UNITRAX C-TAPER SLEEVE -3MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6673255
• Report Number: 0002249697-2017-02059
• Device Sequence Number: 13923771
• Product Code: KWL
• UDI-Device Identifier: 07613327013450
• UDI-Public: 07613327013450
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K992570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 02/21/2022
• Device Catalogue Number: 6942-7-060
• Device Lot Number: 58852402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 10/25/2017
• 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: 78 YR
• Patient Weight: 75