MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 46MM MEDIUM NECK; HIP COMPONENT

Model Number	38014600
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris revision njr number: (b)(4).Side:r.Primary asa: p1 - fit and healthy.Products not revised: 1-product id: pha00240, profemur® z femoral stem size 5 cementless, lot number: ni, qty: 1.2-product id: pha01202, profemur® neck neutral short, lot number: ni, qty: 1.
Event or Problem Description
Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris revision njr number: 4914788 side:r primary asa: p1 - fit and healthy products not revised: 1-productid: pha00240, profemur® z femoral stem size 5 cementless, lot number: 058595929, qty: 1.2-productid: pha01202, profemur® neck neutral short, lot number: 048583129, qty: 1.Additional information received on 9/15/2022: it was stated from uk njr that this looks to be a same day bilateral so there are two sets of implants.However, one set of implants regarding primaryprocedureid # 612754 has an unrevised status.Review of initial documentation provided from njr (excel document) confirms that the set of implants regarding primaryprocedureid # 612754 are not revised.Excel document shows no alleged complaint against the unrevised implants.Unrevised products for primaryprocedureid # 612754 are: 1-productid: pha00240, profemur® z femoral stem size 5 cementless, lot number: 058608693, qty: 1.2-productid: pha01232, profemur® modular femoral neck, lot number: 048577534, qty: 1 3-productid: 38ha4652, conserve® thin shell ha coated 46mm id 52mm od beaded, lot number: 018480873, qty: 1.4-productid: 38014600, conserve® bfh® head 44mm medium neck, lot number: 068605243, qty: 1.

• Brand Name: CONSERVE® BFH® HEAD 46MM MEDIUM NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15365902
• Report Number: 3010536692-2022-00318
• Device Sequence Number: 12343200
• Product Code: KWA
• UDI-Device Identifier: M684380146001
• UDI-Public: M684380146001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 38014600
• Device Catalogue Number: 38014600
• Device Lot Number: 068605243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2022
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown