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

Model Number 74122158

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Unspecified Musculoskeletal problem (4535)

Event Date 09/21/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Internal complaint reference (b)(4).

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.

Manufacturer Narrative

H10: additional information in b5 and h6 (health effect - clinical code and medical device problem code).

Event 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))¿.

Manufacturer Narrative

H11: corrected information was added in section d1, d2, d4 and g4.

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.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• Type of Device: 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
• MDR Text Key: 309251701
• Report Number: 3005975929-2023-00005
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male