MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID28 OD50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6309-2-850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/25/2022
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
The revision is required due to the dislocation and issue noticed during the follow up with the surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving an exeter shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: this patient underwent a left total hip arthroplasty and then approximately two years later sustained a dislocation which according to the summary required revision surgery.I can confirm that the dislocation occurred since i was able to review the x-ray showing the dislocation.I cannot confirm that revision was carried out since i have no documentation supporting that such as operation note, office notes or post-revision xrays.I cannot confirm the root cause of this event.The causes of dislocation two years after a primary total hip arthroplasty are multifactorial including surgical technique, patient bmi and activity levels and implant positioning.With the information provided i would not assign any causality to the implant itself.-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: a review of the provided medical records by a clinical consultant indicated: this patient underwent a left total hip arthroplasty and then approximately two years later sustained a dislocation which according to the summary required revision surgery.I can confirm that the dislocation occurred since i was able to review the x-ray showing the dislocation.I cannot confirm that revision was carried out since i have no documentation supporting that such as operation note, office notes or post-revision xrays.I cannot confirm the root cause of this event.The causes of dislocation two years after a primary total hip arthroplasty are multifactorial including surgical technique, patient bmi and activity levels and implant positioning.With the information provided i would not assign any causality to the implant itself.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
The revision is required due to the dislocation and issue noticed during the follow up with the surgeon.

• Brand Name: EXETER X3 RIMFIT ID28 OD50
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15051092
• Report Number: 0002249697-2022-01044
• Device Sequence Number: 12141269
• Product Code: JDI
• UDI-Device Identifier: 07613327072150
• UDI-Public: 07613327072150
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K111848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 08/31/2023
• Device Model Number: 6309-2-850
• Device Catalogue Number: 63092850
• Device Lot Number: LHN507A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• 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: 70 YR
• Patient Sex: Female