MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/17/2020

Event Type  Injury  

Event Description

It was reported that on literature review "the early to medium-term results of a hemispherical, porous coated acetabular shell with multiple different bearing combinations are excellent with the exception of metal-on-metal," two (2) patients had a two-stage revision surgery due to a deep infection after a tha while using r3 acetabular shell and high offset porous-coated synergy stem.The events were treated by a revision surgery.Patients¿ outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Thompson, z., khoshbin, a., ward, s., waddell, j.P., & atrey, a.(2020).The early-to medium-term results of a hemispherical, porous coated acetabular shell with multiple different bearing combinations are excellent with the exception of metal-on-metal.International orthopaedics, 44(12), 2537-2543.Doi.Org/10.1007/s00264-020-04817-1.

Manufacturer Narrative

H3, h6: it was reported that on literature review 2 patients had a two-stage revision surgery due to a deep infection after a tha while using r3 acetabular shell and high offset porous-coated synergy stem.The events were treated by a revision surgery.Patients¿ outcome is unknown.No further information is available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, sterilization review, device labelling and ifu review could not be performed.A risk management review could not be performed as the devices involved have been phased out from the market and as a result there is no live risk management file to review.Without definitive lot numbers a full review of prior escalation actions cannot be performed for the devices involved.However, using the available information, a search was completed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time without additional information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR
• 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: 13759916
• MDR Text Key: 289526847
• Report Number: 3005975929-2022-00058
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• 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
• Treatment: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE
• Patient Outcome(s): Required Intervention; Hospitalization