MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Fluid Discharge (2686)

Event Date 09/17/2019

Event Type  Injury  

Event Description

It was reported that, on literature review "midterm outcomes of total hip arthroplasty with a modular birmingham head", one (1) patient who underwent primary surgery with a r3-tha construct required a revision surgery due to a postoperative chronic wound drainage which was treated with an irrigation and debridement and an r3 liner exchange at 2 months with the subsequent resolution of the symptoms.A culture was performed and was positive for staphylococcus aureus.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Cushnie, d.W., lanting, b.A., mccalden, r., naudie, d.D., & howard, j.L.(2021).Midterm outcomes of total hip arthroplasty with a modular birmingham head.Hip international, 31(1), 103-108.Doi: doi.Org/10.1177/1120700019877389.

Manufacturer Narrative

H10: additional information in h6 (health effect - clinical code and health effect - impact code).H3, h6.It was reported through a literature article that an irrigation, debridement and revision surgery was performed due to infection.The r3 liner was removed.As of today, the implanted devices, all of which were used in treatment, have not been returned for evaluation.As no device part or batch numbers were provided for investigation, a complaint history, manufacturing record and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.R3 liners have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The literature article was reviewed.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.Without additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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: UNKN R3 METAL LINER IMPL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 13774099
• MDR Text Key: 287815552
• Report Number: 3005975929-2022-00067
• Device Sequence Number: 1
• Product Code: JDG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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: 06/06/2022
• 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