MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Screw that reinforces taper between restoration modular cone body and stem broke during tightening.The torque wrench was used and the surgeon was informed not to exceed (b)(6).The surgeon state[d] that the torque wrench gave way at (b)(6) so he continued to tighten.This was done three times & screw broke on third attempt.The torque wrench may have slipped off screw when it reached 180 in-lbs making the surgeon believe the wrench gave way.The screw was over-torqued beyond safety limits.The surgeon left stem in without the screw.The body and stem taper was securely impacted during the case.
Event or Problem Description
Screw that reinforces taper between restoration modular cone body and stem broke during tightening.The torque wrench was used and the surgeon was informed not to exceed 180 in-lbs.The surgeon state[d] that the torque wrench gave way at 180 in-lbs so he continued to tighten.This was done three times & screw broke on third attempt.The torque wrench may have slipped off screw when it reached 180 in-lbs making the surgeon believe the wrench gave way.The screw was over-torqued beyond safety limits.The surgeon left stem in without the screw.The body and stem taper was securely impacted during the case.
Additional Manufacturer Narrative
The following devices were also listed in this report: torque wrench adaptor; cat# 6260-4-080; lot# tackb0f torque wrench; cat# 6060-2-640; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information: product available to stryker and returned to manufacturer on.An event regarding crack/fracture involving a restoration modular bolt was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: records provided were reviewed by a consulting clinician who indicated insufficient information was received for further review.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the investigation cannot confirm the bolt was fractured as insufficient information was provided.Records provided were reviewed by a consulting clinician who indicated insufficient information was received for further review.Further information such as primary and revision operative reports, serial x-rays, lab, progress notes, and examination of explanted components are needed.Although the event was not confirmed, the event notes the surgeon over-torqued beyond safety limits and this would be a root cause of a fractured bolt.If additional information becomes available, this investigation will be reopened.

• Brand Name: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6916344
• Report Number: 0002249697-2017-02918
• Device Sequence Number: 19160688
• Product Code: LPH
• UDI-Device Identifier: 04546540641083
• UDI-Public: 04546540641083
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• 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): 02/09/2018

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: 04/25/2022
• Device Catalogue Number: 6276-1-023
• Device Lot Number: 52695101
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 02/09/2018
• 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: 77 YR
• Patient Weight: 41