MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120156
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/26/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the plaintiff underwent a total hip arthroplasty (tha) surgery on the right hip on (b)(6) 2009.The x-rays post-operative showed that the implanted acetabular cup had slipped.This complication was solved by conducting a revision surgery on (b)(6) 2009.During the procedure, it was noticed that the inferior edge of the acetabulum had indeed become displaced.The devices were explanted and replaced except for the femoral stem.The patient was taken to the recovery room in good condition.
Additional Manufacturer Narrative
H3, h6: it was reported that right hip revision surgery was performed after the implanted acetabular cup had slipped.During the procedure, it was noticed that the inferior edge of the acetabulum had indeed become displaced.As of today, the devices, which were used in treatment, have not been returned for evaluation.Without lot information a full complaint history review cannot be completed.A partial review of complaints was performed looking for similar incidents involving the same part and failure mode reported within the past year.One complaint was found involving this modular head.No similar complaints were found for the cup.This will continue to be monitored via routine trending, although it should be noted that modular devices are no longer sold.Without batch numbers a review of the manufacturing records could not be performed.Should the batch details be received at a later date this task will be reopened and completed.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations was performed.No prior applicable escalation actions were identified involving the acetabular cup.Based on the limited information provided, the clinical root cause of the displacement of the acetabular cup cannot be confirmed.It cannot be concluded that the reported events are related to a malperformance of the implant.The patient impact beyond the revision surgery cannot be determined.However, six years later, the patient underwent a second revision surgery.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are muscle and fibrous tissue laxity and malpositioning of the implants leading to postoperative joint instability.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 56MM W/ IMPTR
• 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: 17684023
• Report Number: 3005975929-2023-00128
• Device Sequence Number: 14092874
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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 Catalogue Number: 74120156
• Device Lot Number: UNKNOWN
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODULAR SLEEVE -4MM 12/14.; RESURFACING FEMORAL HEAD 50MM.; UNKN SYNERGY HIP STEM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male