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

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/04/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 309009242
• Report Number: 0002249697-2023-00141
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic