MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1440-2011
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Primary procedure, left hip.It was reported that after impacting the shell, the impacting bolt was cold-welded into the shell and could not be removed.The construct was removed and another shell implanted with a screw.Surgery was completed successfully with a delay of approximately 10 minutes.
Event or Problem Description
Primary procedure, left hip.It was reported that after impacting the shell, the impacting bolt was cold-welded into the shell and could not be removed.The construct was removed and another shell implanted with a screw.Surgery was completed successfully with a delay of approximately 10 minutes.
Additional Manufacturer Narrative
Reported event: an event regarding disassembly issue involving a da instrument bolt was reported.The event was confirmed through visual inspection.Method & results: product evaluation and results: visual inspection of the returned device noted the following: examination of returned device indicated that the bolt was tightly fastened to the shell as described by the event details.Failure mode is confirmed.The device was separated for material analysis.Material analysis: damage consistent with the implantation/ explantation process was observed on the male threads of the impactor bolt.Hardness was performed on the flat portion of the bolt threads in accordance with astm e18.The hardness was observed to be approximately 47 hrc, meeting the drawing requirement of 40 hrc minimum.X-ray fluorescence spectroscopy energy dispersive spectroscopy showed the material is consistent with a 17-4 ph stainless steel alloy, which is consistent with the drawing.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.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative report as well as additional information from the user are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CUP IMPACTOR BOLT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; IE NA
• MDR Report Key: 9541245
• Report Number: 0002249697-2020-00012
• Device Sequence Number: 2341513
• Product Code: LPH
• UDI-Device Identifier: 07613327196245
• UDI-Public: 07613327196245
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• 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): 04/06/2020

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 Model Number: 1440-2011
• Device Catalogue Number: 1440-2011
• Device Lot Number: ERDAK6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: 46 YR
• Patient Weight: 80