MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT PSL SHELL/CLUSTER HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	2050-2044
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	11/12/2002
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary tha surgery was performed on (b)(6) 1997.Revision surgery was performed for osteolysis on (b)(6) 2002.Head and liner was replaced.2nd revision surgery was performed for dislocation of a joint on (b)(6) 2016.Cup, liner, head, and screw were replaced.3rd revision surgery was performed for pseudotumor caused by armd (b)(6) 2024.Stem, head, liner and screws were replaced.This pi is for 2nd revision surgery.
Event or Problem Description
Primary tha surgery was performed on (b)(6)1997.Revision surgery was performed for osteolysis on (b)(6)2002.Head and liner was replaced.2nd revision surgery was performed for dislocation of a joint on (b)(6) 2016.Cup, liner, head, and screw were replaced.3rd revision surgery was performed for pseudotumor caused by armd (b)(6) 2024.Stem, head, liner and screws were replaced.This pi is for 2nd revision surgery.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a securfit shell was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review with a clinical consultant indicated" confirmation of event: i can confirm that the patient had a primary left total hip arthroplasty since an operation report albeit in japanese was provided with handwritten illustrations.I can also confirm that the patient had revision surgery also because i was able to look at an operation report also in japanese.I can also confirm that the patient had yet another revision also because i was able to look at a japanese written operation report.I cannot interpret details.Root cause analysis: the root cause of these events cannot be determined with certainty.Patient underwent a primary surgery, a revision surgery for osteolysis, a second revision surgery for dislocation and a third revision surgery for pseudotumor.The causes of these issues are multifactorial including surgical technique, the way the implants are positioned and aligned, as well as proper restoration of soft tissue tension in the thigh.Also to be considered is the proper preparation of the head and trunnion prior to and during insertion, patient factors including lifestyle, activity level and bmi, as well as implant factors." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: 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, pre- and post-operative x-rays 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.

• Brand Name: SECUR-FIT PSL SHELL/CLUSTER HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 20552966
• Report Number: 0002249697-2024-01469
• Device Sequence Number: 3224877
• Product Code: LZO
• UDI-Device Identifier: 07613327019902
• UDI-Public: 07613327019902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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 Catalogue Number: 2050-2044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian