MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported via the stryker facebook page, "i really wish he would have had the robot when he did my hip surgery it's still screwed up it's too high and way too deep and laid back is blown out because of all of it as well i kept telling him it wasn't healing like he just didn't want to listen to".Additional facebook comments received; oh yes it is people have had good results with it my hip is screwed up because he did not have it he tried to do it himself he could not.

Manufacturer Narrative

An event regarding malposition involving an unknown hip was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-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: it was reported that the patient's hip implant "is too high and way too deep." 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: UNKNOWN_HIP
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19179748
• MDR Text Key: 341007543
• Report Number: 0002249697-2024-00644
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2024
• 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): Other