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

Model Number 502-03-52D

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/02/2022

Event Type  Injury  

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.Device not available.

Event Description

Revision report as below: "primary hip done 2 years ago.Patient has complained of pain ever since having it done.Bone scans were conducted.First scan was thought to be fine.Requested a second scan and decided it showed subtle signs of loosening.The cup was removed during the revision ¿very easily¿ and that no bone growth was evident on the cup thus was microscopically loose.".

Manufacturer Narrative

Corrected data g1 manufacturing site for devices to sho.An event regarding loosening involving a trident 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 information by a clinical consultant indicated: "the revision operative report describes the acetabulum as being clinically loose with no bony ingrowth.Revision tha surgery for loss of/lack of bony ingrowth of the acetabulum is confirmed.The root cause of lack of ingrowth cannot be determined from this limited amount of documentation." 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: it was reported that the patient was revised due to loosening of the shell.The event was confirmed via clinician review of the provided medical records.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 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.

Event Description

Revision report as below: "primary hip done 2 years ago.Patient has complained of pain ever since having it done.Bone scans were conducted.First scan was thought to be fine.Requested a second scan and decided it showed subtle signs of loosening.The cup was removed during the revision ¿very easily¿ and that no bone growth was evident on the cup thus was microscopically loose".

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15852872
• MDR Text Key: 304196410
• Report Number: 0002249697-2022-01724
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040128
• UDI-Public: 07613327040128
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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: 05/26/2024
• Device Model Number: 502-03-52D
• Device Catalogue Number: 502-03-52D
• Device Lot Number: LL8V0L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 02/11/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG