MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM; HIP COMPONENT

Model Number	38AM4035
Medical Device Problem Codes	Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to unknown reasons.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.The provided incident report states that this patient was revised resulting from "surgeon preference regarding patient condition." microport post market quality contacted the reporting sales representative regarding the possible causes concerning the described patient condition, but the sales representative did not provide any additional information related to this event.Review of the device history record (dhr) for this lot indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no lot trends for any complaint modes.There is not enough information to investigate this complaint.No information regarding a product failure or any specific complications were made available.This investigation will be reopened if additional information is received.
Additional Manufacturer Narrative
Updated: description, events' codes and investigation codes were changed.
Event or Problem Description
Allegedly, patient was revised due to unknown reasons.Additional information received on 03/21/2023: allegedly, on or about (b)(6) 2021 plaintiff reported for a revision/replacement if the femoral head and neck.Dr recommended the revision surgery after plaintiff presented with pain and weakness, adverse local tissue reaction and elevated cobalt levels.Neck (pha01242) and head (pha04426) were implanted during the revision surgery.Products not revised: product id: lot number: qty: 20070031 1830209 1.Dspcgf56 1822203 1.Pha00248 01112839031803042 1.Dlxplf40 15418741813633 1.18080304 177194 1.18080303 1802295 1.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM
• 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: 12908463
• Report Number: 3010536692-2021-00571
• Device Sequence Number: 17112242
• Product Code: KWA
• UDI-Device Identifier: M68438AM40351
• UDI-Public: M68438AM40351
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 38AM4035
• Device Catalogue Number: 38AM4035
• Device Lot Number: 05113488501805518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 10/13/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Female