MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR GLADIATOR CEMENTED STEM SZ 4; HIP COMPONENT

Model Number	PRGLCM04
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Sade # (b)(4).Allegedly, patient was revised due to pain and loosening.Trochanteric non-union due to inadequate reattachment and or early weight bearing.He has had lack of ingrowth of the acetabular component.Operative side: right.The dynasty biofam shell, dynasty a-class polyliner, and screws were revised.Components not revised: product name: profemur® neck a/r 8dg short cobalt chrome catalog number: phac1232 lot number: 1407107.Product name: profemur® gladiator® cemented stem sz 4 catalog number: rglcm04 lot number: 1453286.Product name: conserve® a-class® bfh® head short neck 36mm catalog number: 38am3604 lot number: 1452346.

• Brand Name: PROFEMUR GLADIATOR CEMENTED STEM SZ 4
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12381673
• Report Number: 3010536692-2021-00453
• Device Sequence Number: 14469838
• Product Code: JDI
• UDI-Device Identifier: M684PRGLCM041
• UDI-Public: M684PRGLCM041
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Other
• Device Model Number: PRGLCM04
• Device Catalogue Number: PRGLCM04
• Device Lot Number: 1453286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR