MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 FEM HEAD ORTHINOX 32+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6364-2-232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	09/03/2014
Type of Reportable Event	Serious Injury
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.Device not returned.
Event or Problem Description
Patient had a dislocation of their left hip.The acetabular cup was removed and a cement in cement revision performed using a 48mm cemented constrained cup.The hip was reduced with a 22 + 3mm stainless steel head.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a metal head was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: not performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: revision surgeries were confirmed x 3.The original revision appeared to be for an infection.The second revision for recurrent dislocation and the reasons for the third revision were not entirely clear.At that final revision, stem-polyethylene impingement was noted with fracture of the constrained liner and burnishing of the stem¿s neck.Root cause: while the root causes could not be completely defined by the materials provided, it appeared that the root cause of the first revision was infection and the second recurrent dislocation.The root cause of the third revision could not be defined.The impingement of the stem-liner noted at the third revision may well have been to result of differing root cause for the revision.[.]" -product history review: review of the device history records indicate the 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.Conclusion: a review of the provided medical information by a clinical consultant confirmed the dislocation event.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 pre- and post-operative x-rays 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
Patient had a dislocation of their left hip.The acetabular cup was removed and a cement in cement revision performed using a 48mm cemented constrained cup.The hip was reduced with a 22 + 3mm stainless steel head.Update 14/jan/2022: medical records indicate that the exeter stem was not revised during this procedure.Timeline of events per medical records: first revision on (b)(6), 2014 due to infection, second revision on (b)(6), 2014 due to recurrent dislocations (this pi), and third revision on (b)(6), 2021 due to constrained liner impingement which had lead to excessive plastic wear and the liner's locking ring breaking.

• Brand Name: V40 FEM HEAD ORTHINOX 32+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12739868
• Report Number: 0002249697-2021-01820
• Device Sequence Number: 4703093
• Product Code: JDI
• UDI-Device Identifier: 04546540273390
• UDI-Public: 04546540273390
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 6364-2-232
• Device Catalogue Number: 6364-2-232
• Device Lot Number: G3212786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female