MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM; HIP COMPONENT

Model Number	38AM5004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Reaction (2414); Metal Related Pathology (4530)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
Event or Problem Description
Allegedly, patient was revised due to adverse local tissue reaction.Additional information: right hip.
Additional Manufacturer Narrative
See attached.Updated section b event or problem description, section e and f initial reporter information.The device has not been explanted as stated on the previous report.- attachment: [wd011615.Pdf].
Event or Problem Description
Allegedly, patient was diagnosed with an adverse local tissue reaction.Additional information: right hip.
Additional Manufacturer Narrative
10.Additional manufacturer narrative: additional information received.Corresponding sections updated.Section h.6 codes remain the same as previously reported.11.Corrected data: event description updated (section b.5).
Event or Problem Description
Allegedly, patient was diagnosed with an adverse local tissue reaction.Additional information on 07-02-2021: right hip additional information received on 07/02/2021, stating that there was elevated blood cobalt.It is recommended to do a revision surgery on patient.The device will be scheduled for explant.
Additional Manufacturer Narrative
10.Additional manufacturer narrative: additional information received.Corresponding sections updated.Section h6 codes remain the same as previously reported.11.Corrected data: event description updated (section b5).
Event or Problem Description
Allegedly, patient was diagnosed with an adverse local tissue reaction.Additional information on 07-02-2021: right hip.Additional information received on 07/02/2021, stating that there was elevated blood cobalt.It is recommended to do a revision surgery on patient.The device will be scheduled for explant.Additional information received on 04/oct/2021 and 11/oct/2021 stating that the recommended revision surgery was completed on (b)(6) 2021.The femoral head and the pseudotumor were removed.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM
• 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: 9722062
• Report Number: 3010536692-2020-00132
• Device Sequence Number: 366840
• Product Code: KWA
• UDI-Device Identifier: M68438AM50041
• UDI-Public: M68438AM50041
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2021

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: 38AM5004
• Device Catalogue Number: 38AM5004
• Device Lot Number: 068646166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020; 01/24/2020; 01/24/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 05/19/2020; 08/01/2021; 11/08/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 137 KG