MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Catalog Number 74122158

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that revision surgery was performed in (b)(6) 2016.Devices implanted in (b)(6) 2013.Pain, squeaky noises, elevated cobalt and chromium levels reported.

Manufacturer Narrative

Manufacturer Narrative

[(b)(4)].

Event Description

It was reported that the patient underwent a revision surgery of the left hip on (b)(6)2016 due to due to constant pain, squeaky noises, and high cobalt and chromium levels in blood.Primary left hip bhr resurfacing surgery was performed on (b)(6) 2013.

• Brand Name: BHR ACETABULAR CUP 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 5534830
• MDR Text Key: 41457059
• Report Number: 3005477969-2016-00073
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/07/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 74122158
• Device Lot Number: 11KW34510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided; 03/27/2016; 04/02/2024; 05/02/2024
• Supplement Dates FDA Received: 05/09/2016; 04/12/2018; 04/23/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121146, LOT # UNKNOWN; FEMORAL HEAD, # 74123152, LOT # 11KW34534
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male