MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number	6942-7-065
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product 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
Opened a unitrax sleeve, ctpr, +0, ref (b)(4), lot 58877002.Sleeve was placed in unitrax head, correctly, then the surgeon attempted to impact it on a size 5, omnifit, ctpr stem.Taper did not engage.Sleeve spun around on trunnion of stem.Ctpr trialing fit correctly prior and during situation.
Additional Manufacturer Narrative
Reported event: an event regarding a size/fit issue involving a sleeve was reported.The event was not confirmed.Dimensional & functional inspection: not performed as there is evidence from the visual inspection that the device is damaged.Material analysis; ma - damage observed on the sleeve consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
Opened a unitrax sleeve, ctpr, +0, ref (b)(4), lot 58877002.Sleeve was placed in unitrax head, correctly, then the surgeon attempted to impact it on a size 5, omnifit, ctpr stem.Taper did not engage.Sleeve spun around on trunion of stem.Ctpr trialing fit correctly prior and during situation.

• Brand Name: UNITRAX C-TAPER SLEEVE +0MM
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8005047
• Report Number: 0002249697-2018-03495
• Device Sequence Number: 1189784
• Product Code: KWL
• UDI-Device Identifier: 07613327013467
• UDI-Public: 07613327013467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/14/2018

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: 02/28/2022
• Device Catalogue Number: 6942-7-065
• Device Lot Number: 58877002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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
• Patient Age: 86 YR
• Patient Weight: 43