MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL® PRIME BF QUAD SHELL 52 MM GROUP C; HIP COMPONENT

Model Number	P3SBQC52
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Sae #(b)(6): allegedly, reports continued drainage for his right hip wound.Additionally, he complaints of tiredness and fatigue but denies any subjective fevers.He feels the wound drainage is remain unchanged in volume since his last visit 2 days ago.Physical examination: alert, cooperative oriented 1 cm one defect continued drainage surrounding erythema no pain with gentle range of motion nvi.Investigations: x-ray: no evidence of subsistence femoral head concentric within the acetabular cup.Impression/plan: 3 weeks out for right total hip arthroplastic.Unfortunately he had has several instability events with continued drainage from his right hip wound.Additionally, he had a il-6 lab drawn on monday which has come back 18.6.Given his 3 week a out this number should be roughly normalized around 10.Based in these factors there is a considerable chance that patient potentially has a deep infection.Will admit him with plans for irrigation debridement has possible revision.Sae #(b)(6): additional information received for products and lots on date 08/23/2022.
Additional Manufacturer Narrative
Section h.6: investigation codes have been updated.

• Brand Name: PROCOTYL® PRIME BF QUAD SHELL 52 MM GROUP C
• 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: 15414285
• Report Number: 3010536692-2022-00323
• Device Sequence Number: 17520912
• Product Code: LPH
• UDI-Device Identifier: M684P3SBQC521
• UDI-Public: M684P3SBQC521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/11/2022

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: P3SBQC52
• Device Catalogue Number: P3SBQC52
• Device Lot Number: 1850936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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