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

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding malposition involving an unknown shell was reported.The event of revision was confirmed by provided photo but no device failure mode was reported or confirmed.Method & results: product evaluation and results: the reported device was not returned however a photograph was provided for review.The photo displayed recently explanted femoral head, stem and shell with liner assembled in it.There are blood and tissue on the stem and shell.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported that the shell was revised to a tritanium revision shell due to incorrect positioning from the original surgery.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, reason for revision, 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.Device not returned.

Event Description

Patient came to (b)(6) clinic on evening thursday (b)(6) 2020 complaining their hip felt dislocated.An x-ray revealed an accolade stem with severe trunnion wear.The femoral head was off the trunnion.During surgery metallosis was discovered with a worn trunnion.A 36 mm +5 lfit femoral head was completely off the neck of the stem.After removal of the accolade stem a restoration modular stem was used an a tritanium revision shell was used with a poly liner.A 36mm biloxi delta femoral head was used.Update: "first it was the left side.Implant date was (b)(6) 2008.This was only the first revision." update: "the shell was replaced due to incorrect positioning from the original surgery.".

• Brand Name: UNKNOWN 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10598462
• MDR Text Key: 208939998
• Report Number: 0002249697-2020-02007
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82