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

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.

Event Description

It was reported that the patient's hip was revised.As reported by rep: "patient stem revised after cement mantle cracked due to osteolysis.The cup is [competitor]." manufacturer of cement unknown.There are no allegations against the revised head.Patient revised to a restoration ha stem and another femoral head.Rep provided an x-ray and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN OMNIFIT STEM
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 10501771
• MDR Text Key: 205911324
• Report Number: 0002249697-2020-01808
• 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: 09/08/2020

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/08/2020
• 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: 96 YR
• Patient Weight: 67