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); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding disassembly issue involving a da instrument bolt was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left hip.It was reported that the offset cup inserter became stuck in the cup.The construct was removed and another shell implanted.Surgery was completed successfully with a delay of approximately 5-10 minutes.Rep provided the usage sheet showing the wasted shell, and confirmed that no further information will be released by the hospital or surgeon.Update per sales rep on june 1, 2021: the product in question is the bolt 1440-2011.
Additional Manufacturer Narrative
Reported event: an event regarding disassembly issue involving a da instrument bolt was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device ( the two devices were returned assembled) indicates nothing remarkable to report dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: the two devices were returned assembled.The devices were unable to be disassembled by hand; however were disassembled with tools.Functional testing was performed with the bolt and shell after disassembly and were able to assemble and disassemble without issue.Material analysis: not performed as this event does not relate to material integrity.-clinician review: 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.  conclusions: functional testing was performed with the bolt and shell after disassembly and were able to assemble and disassemble without issue.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left hip.It was reported that the offset cup inserter became stuck in the cup.The construct was removed and another shell implanted.Surgery was completed successfully with a delay of approximately 5-10 minutes.Rep provided the usage sheet showing the wasted shell, and confirmed that no further information will be released by the hospital or surgeon.Update per sales rep on june 1, 2021: the product in question is the bolt (b)(4).

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 11974023
• Report Number: 0002249697-2021-01004
• Device Sequence Number: 3388341
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 12/31/2024
• Device Model Number: 1440-2011
• Device Catalogue Number: 1440-2011
• Device Lot Number: ERFPK6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 126 KG