MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122158
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Unspecified Musculoskeletal problem (4535)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after left bhr revision surgery was performed on (b)(6) 2022 due to unknown complications, the plaintiff underwent a posterior capsule mesh reconstruction on (b)(6) 2022 to repair the extensive damage to his left hip caused by the defective metal-on-metal implant.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: a reassessment identified that this event should be re-evaluated for mdr reporting.It was determined that, since the additional surgery performed on (b)(6) 2022 took place after the smith and nephew implants were removed, the issue initially reported under (b)(4) does not meet the threshold for reporting and therefore, it has been included in the same event in (b)(4).If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
Additional Manufacturer Narrative
H11: corrected information was added in section d1, d2, d4 and g4.
Additional Manufacturer Narrative
H11: a reassessment identified that this event should be re-evaluated for mdr reporting.It was determined that, since the additional surgery performed on (b)(6) 2022 took place after the smith and nephew implants were removed, the issue initially reported under (b)(4) does not meet the threshold for reporting and therefore, it has been included in the same event in (b)(4).If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.(b)(4) is our internal reference for the report number: 3005975929-2023-00006.
Additional Manufacturer Narrative
H10: additional information in b5 and h6 (health effect - clinical code and medical device problem code).
Event or Problem Description
It was reported that the plaintiff suffered from a left hip dislocation on (b)(6) 2022 and underwent a posterior capsule mesh reconstruction on (b)(6) 2022 to repair the extensive damage to his left hip caused by the defective metal-on-metal implant.This patient had already suffered a left hip revision surgery on (b)(6) 2022 due to unknown complications (covered under (b)(4))¿.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16342939
• Report Number: 3005975929-2023-00005
• Device Sequence Number: 6803963
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/13/2023

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: Health Professional
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 08GW17648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023; 05/01/2023; 05/31/2023; 07/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/20/2023; 05/25/2023; 05/31/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male