MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	500-03-52D
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to aseptic loosening of the acetabular component.A shell, head, and liner were revised.
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
Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed via clinician review.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of medical records by a clinical consultant indicated: "this inquiry concerns a patient who developed aseptic loosening of his right acetabular component which required revision to an mdm articulation.I can confirm that the revision was carried out since i was able to review the operation report.The causes of aseptic loosening of an acetabular component several years after surgery are multifactorial and i cannot determine the root cause with certainty.Influencing factors include surgical technique, patient activity level and bmi.With the information provided i would not attribute any causality to the implant itself" 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 reported lot.Conclusion: a review of medical records by a clinical consultant indicated: "this inquiry concerns a patient who developed aseptic loosening of his right acetabular component which required revision to an mdm articulation.I can confirm that the revision was carried out since i was able to review the operation report.The causes of aseptic loosening of an acetabular component several years after surgery are multifactorial and i cannot determine the root cause with certainty.Influencing factors include surgical technique, patient activity level and bmi.With the information provided i would not attribute 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
It was reported that the patient's right hip was revised due to aseptic loosening of the acetabular component.A shell, head, and liner were revised.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16315859
• Report Number: 0002249697-2023-00141
• Device Sequence Number: 7843694
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 07/31/2017
• Device Model Number: 500-03-52D
• Device Catalogue Number: 500-03-52D
• Device Lot Number: MLL2DN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic