MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6276-1-025
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding disassociation with femoral head involving a restoration modular body and disassembly issue between the restoration modular body and a restoration modular stem was reported.The event of disassociation was confirmed via clinician review, while the event of disassembly issue 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: a review of the provided medical information by a clinical consultant indicated: "based upon the information supplied in this inquiry including the inquiry layout and x-rays supplied, i can confirm that the prosthetic femoral head did indeed displace due to either fracture or erosion/dissolution of the implant¿s femoral neck/trunnion.[.] based upon the information supplied and the supporting documentation provided by the stryker rep i can confirm that damage to the implant occurred during attempts at removal that was attributed to the extraction instrument failing twice, necessitating attempts at removal by other means (mallet and midas).It appears that the use of these tools and other means damaged the implant such that a simple exchange of the body could not be performed and the procedure developed into a full revision of the stem.[.] in addition to the penciling of the trunnion, there is a distinct notch on the inferior aspect of the femoral neck of the restoration modular component.In addition, this component was utilized with a non-stryker product for the acetabulum and polyethylene component.I would expect that this is off label.Possibility of impingement as a contributing cause to perhaps loosening of the femoral head on the trunnion and then subsequent erosion and failure is considered.In addition, the femoral head may not have been impacted fully or the trunnion inadequately prepared (leaving debris, blood, etc.) that could result in a loose fit, leading to erosion.[.] i am somewhat skeptical about whether or not it was used in a proper fashion.Also, if the instruments failed, i am not sure i would use a midas rex to access the trunnion of the body and the stem.One could always insert the ¿inserter¿ and use a slap hammer to remove the body and stem at the same time." product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 17-jan-2012 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported the device was revised due to disassociation (head breaking off the trunnion).It was also reported that the center post of the device was intraoperatively fractured and the stem/ neck junction was damaged when attempting to remove, which contributed to the surgery delay.Clinician review of provided medical records indicated that the prosthetic femoral head did indeed displace due to either fracture or erosion/dissolution of the implant¿s femoral neck/trunnion.The clinician thought the intraoperative fracture is likely related to use of instruments.However, no conclusive indication was provided by the clinician regarding the stem fracture.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 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
It was reported that the patient's right hip was revised due to the head breaking off the trunnion.Patient is active and involved with manual labor.A femoral head and restoration modular proximal body were revised.Due to intra-operative damage to the stem/ neck junction, the restoration modular distal stem was also revised, adding 60 to 90 minutes to the procedure (intra-op event reported).Rep can provide additional pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.Update 11/february/2021 wg: the rep is unaware if the shell or liner, which are competitor devices, were revised.

• Brand Name: 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11405370
• Report Number: 0002249697-2021-00367
• Device Sequence Number: 19678454
• Product Code: JDI
• UDI-Device Identifier: 04546540641090
• UDI-Public: 04546540641090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 6276-1-025
• Device Catalogue Number: 6276-1-025
• Device Lot Number: 38797505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/03/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR