MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT COLLARLESS STEM COCR MOLD#145; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 1003-0525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

An event regarding revision involving an omnifit stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: the device was not returned however explanted photographs were provided for review.Scratch marks can be noted on the surface of stem that are most likely from the explantation process.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity.Clinical review: no medical records were received for review with a clinical consultant. product 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.  conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Not returned to the manufacturer.

Event Description

Rep left a voicemail reporting that the patient's right hip was revised.An omnifit stem, 32mm head, and a 'cup' were revised to a restoration modular stem construct, a femoral head, and a 'cemented cup'.Update 12/march/2021 wg: spoke to rep.Patient was revised due to pain and apparent osteolysis around the shell, intra-operatively, the liner was observed to be worn through nearly to the inside of the shell, and deformed.Upon removing the shell, the patient's acetabulum was noted to be black.The entire construct was revised including a cemented shell.The rep provided an intra-operative picture and a picture of the explants and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: OMNIFIT COLLARLESS STEM COCR MOLD#145
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11601110
• MDR Text Key: 243728753
• Report Number: 0002249697-2021-00585
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K844818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2021

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: 1003-0525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/01/2021
• 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: 81 YR