MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 52E TRIDENT HEMISPHERICAL CLUSTERHOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

It was reported that the patient's left hip was revised.After initial patient complaint of pain, mri showed an effusion.Bloody fluid was aspirated and infection was ruled out.Intra-operatively, surgeon suspected shell was loose (rep not made aware if this was confirmed).The shell, a screw, mdm metal liner, adm/ mdm poly insert, and ceramic head were revised.

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as device identification and 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.Catalog numbers and lot codes of other devices listed in this report: unknown mdm metal liner lot unknown.Unknown adm/ mdm poly insert lot unknown.Unknown 28 +0 biolox head lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's left hip was revised.After initial patient complaint of pain, mri showed an effusion.Bloody fluid was aspirated and infection was ruled out.Intra-operatively, surgeon suspected shell was loose (rep not made aware if this was confirmed).The shell, a screw, mdm metal liner, adm/ mdm poly insert, and ceramic head were revised.

• Brand Name: UNKNOWN 52E TRIDENT HEMISPHERICAL CLUSTERHOLE SHELL
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15936864
• MDR Text Key: 305039330
• Report Number: 0002249697-2022-01786
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/15/2023

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 Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female