MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR FEMORAL HEAD 28MM SLT TAPER +7MM NECK; HIP COMPONENT

Model Number	26012804
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
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
Allegedly, patient has been experiencing pain from around 9 months post-op and blood tests showed raised metal ion levels.Revision was performed to remove the original stem and 28mm metal skirted head.There is metal-on-metal wear on the trunnion.
Event or Problem Description
Allegedly, patient has been experiencing pain from around 9 months post-op and blood tests showed raised metal ion levels.Revision was performed due to lysis, to remove the original stem and 28mm metal skirted head.There is metal on-metal wear on the trunnion.Revision njr number: (b)(4).Side: r primary asa: p2 - mild disease not incapacitating.Non-revised products: product id: pha06254 acetabular cup "procotyl® l" beaded coated+hap 44 grp b/ lot number: 1663283/ qty: 1.Product id: pha04604 rim-lock "a-class®" acetabular poly liner 0° size 28 group b/ lot number: 385786881650139/ qty: 1.
Additional Manufacturer Narrative
Section a.1: additional information in patient / section b.5: additional information in description/ section h.6: health code added.

• Brand Name: COCR FEMORAL HEAD 28MM SLT TAPER +7MM 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: 15131753
• Report Number: 3010536692-2022-00259
• Device Sequence Number: 20275300
• Product Code: LPH
• UDI-Device Identifier: M684260128041
• UDI-Public: M684260128041
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 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: 26012804
• Device Catalogue Number: 26012804
• Device Lot Number: 1676768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 12/19/2022
• 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: Female