MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID28 OD46; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6309-2-846
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/26/2022
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
It was reported by the sales rep that there is revision surgery - cup revision due to dislocation of the hip after surgery in (b)(6) 2022.
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 was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: i can confirm that the patient underwent a primary total hip arthroplasty and sustained a subsequent dislocation, and then underwent a revision procedure for instability treated with a constrained articulation.I can do so because i was able to see the x-rays associated with these events.I cannot determine the root cause with certainty.Causes of early postoperative dislocation are multifactorial including surgical technique factors, especially repair of the capsule and muscle layers, positioning of the implants, patient activity factors including bmi and adherence to postoperative instructions, and trauma if present.I would not assign any causality to the implant system 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: i can confirm that the patient underwent a primary total hip arthroplasty and sustained a subsequent dislocation, and then underwent a revision procedure for instability treated with a constrained articulation.I can do so because i was able to see the x-rays associated with these events.I cannot determine the root cause with certainty.Causes of early postoperative dislocation are multifactorial including surgical technique factors, especially repair of the capsule and muscle layers, positioning of the implants, patient activity factors including bmi and adherence to postoperative instructions, and trauma if present.I would not assign any causality to the implant system 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
It was reported by the sales rep that there is revision surgery - cup revision due to dislocation of the hip after surgery in (b)(6) 2022.

• Brand Name: EXETER X3 RIMFIT ID28 OD46
• 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: 15264539
• Report Number: 0002249697-2022-01201
• Device Sequence Number: 17761274
• Product Code: JDI
• UDI-Device Identifier: 07613327072136
• UDI-Public: 07613327072136
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 04/30/2026
• Device Model Number: 6309-2-846
• Device Catalogue Number: 63092846
• Device Lot Number: LKS 384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2021
• 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: 80 YR
• Patient Sex: Female