MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT SER. II INSERT-10 DEG.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2041-2858
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/29/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a dislocation.Revised liner to a constrained liner.The exeter stem was removed and replaced during the procedure.Right hip.
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.
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
Patient had a dislocation.Revised liner to a constrained liner.The exeter stem was removed and replaced during the procedure.Right hip.
Event or Problem Description
Patient had a dislocation.Revised liner to a constrained liner.The exeter stem was removed and replaced during the procedure.Right hip.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving an omnifit liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports multiple complications of a right total hip replacement.It was implanted in 2003, sustained recurrent dislocations and was revised with a hooded liner.In 2005 the patient dislocated again and was revised to a constrained liner.He did well until 2022 when his femoral component fractured and he was revised again.I can confirm that these events took place since i was able to see the stickers of the implants used, such as the 10- degree hooded liner for the first revision, the constrained liner for the second revision and photos of the fractured implant and post-revision xray.Handwritten notations of the two earlier revision surgeries are also present.Regarding the possible root causes of this events, i cannot determine it with certainty.Causes of late dislocation are multifactorial including surgical technique factors and patient activity factors.Causes of stem fracture are also multifactorial including surgical technique factors, patient activity factors, patient weight and implant factors.Device 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.Conclusion: a review of the provided medical records indicated: this inquiry reports multiple complications of a right total hip replacement.It was implanted in 2003, sustained recurrent dislocations and was revised with a hooded liner.In 2005 the patient dislocated again and was revised to a constrained line.He did well until 2022 when his femoral component fractured and he was revised again.I can confirm that these events took place since i was able to see the stickers of the implants used, such as the 10- degree hooded liner for the first revision, the constrained liner for the second revision and photos of the fractured implant and post-revision xray.Handwritten notations of the two earlier revision surgeries are also present.Regarding the possible root causes of this events, i cannot determine it with certainty.Causes of late dislocation are multifactorial including surgical technique factors and patient activity factors.Causes of stem fracture are also multifactorial including surgical technique factors, patient activity factors, patient weight and implant factors.Further information such as device return, pre- and post-operative x-rays, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: OMNIFIT SER. II INSERT-10 DEG.
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13452129
• Report Number: 0002249697-2022-00180
• Device Sequence Number: 15002389
• Product Code: LPH
• UDI-Device Identifier: 04546540035400
• UDI-Public: 04546540035400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 06/30/2004
• Device Model Number: 2041-2858
• Device Catalogue Number: 2041-2858
• Device Lot Number: 40972101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/1999
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 93 KG