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

Model Number	1440-2011
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Cup impactor bolt in dsa instrument was not removed from trident ii cup after impacting with curved cup bolt impactor during cup insertion.They were not separated even after sterilization.There were not additional items can be replaced, so that the items in other company were used in the case.10 to 15 minutes surgical delay occur for replacing the products.
Event or Problem Description
Cup impactor bolt in dsa instrument was not removed from trident ii cup after impacting with curved cup bolt impactor during cup insertion.They were not separated even after sterilization.There were not additional items can be replaced, so that the items in other company were used in the case.10 to 15 minutes surgical delay occur for replacing the products.
Additional Manufacturer Narrative
Reported event: an event regarding disassembly issue involving a da instrument bolt was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned devices indicated that the shell and the bolt were assembled and could not be disassembled by hand or with tools.Damage consistent with attempted implantation/explantation is visible on the surfaces of the devices.The reported event is confirmed.Material analysis not performed as the devices could not be disassembled.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the shell impactor bolt in dsa instrument could not be removed from trident ii cup after impacting with curved cup bolt impactor during cup insertion.They were not separated even after sterilization.The exact cause of the event could not be determined.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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13248192
• Report Number: 0002249697-2022-00075
• Device Sequence Number: 4520811
• Product Code: LPH
• UDI-Device Identifier: 07613327196245
• UDI-Public: 07613327196245
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K123604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 10/31/2024
• Device Model Number: 1440-2011
• Device Catalogue Number: 1440-2011
• Device Lot Number: ERFPK4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female