MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number 626-00-46F

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "revision of left acetabular component.Surgeon states patient is physically active and presented with pain and fracture of acetabulum.Surgeon states significant adverse local tissue reaction noted during surgery.Surgeon states cup was well fixed." spoke to rep.Rep confirmed patient is very physically active (waterskiing, 72-hole golf, gym, etc).Intra-operatively, the surgeon confirmed that the mdm metal liner was well fixed and well positioned in the shell.Surgeon also confirmed there was no impingement on the femoral stem, and could not provide any possible cause or contributor to altr.A shell with dome hole plug, mdm metal liner, adm/ mdm poly insert, and v40 biolox ceramic head were revised.Rep confirmed there are no allegations against the revised poly insert or ceramic head.Rep provided imaging and primary implant report and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12495369
• MDR Text Key: 272151350
• Report Number: 0002249697-2021-01572
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103233
• 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: 09/20/2021

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 Expiration Date: 06/30/2023
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 65543504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• 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: 54 YR
• Patient Weight: 103