MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID INTL COCR LINER 56MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71335856

Device Problem Biocompatibility (2886)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a primary bhr tha right hip surgery done on (b)(6) 2008, the patient experienced tha m-m and adverse local soft tissue reaction.This condition was treated by performing a revision surgery on (b)(6) 2014.During this revision the liner, the head and the stem were explanted and replaced with unknown components.The current health status of the patient is unknown.

Manufacturer Narrative

Section h3, h6: it was reported that, after a primary bhr total hip arthroplasty right hip, the patient experienced adverse local soft tissue reaction.This condition was treated by performing a revision surgery.During this revision the liner, the head and the stem were explanted and replaced with unknown components.The current health status of the patient is unknown.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and no other similar complaints have been identified for the liner, sleeve, shell and femoral component.This failure will continue to be monitored for the shell and femoral components; and will continue to be monitored via routine trending for the head, sleeve and liner, however it should be noted that these devices are no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.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 for the shell and femoral component; and prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible for the head, liner and sleeve.No further escalation actions are required.The available medical documents were reviewed.With the limited information provided the clinical root cause of the adverse local tissue reaction cannot be confirmed.It cannot be concluded the reported clinical reaction was associated with a mal performance of the implant.The patient impact beyond the revision cannot be determined.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 excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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.H6: health effect - clinical code.

• Brand Name: R3 44MM ID INTL COCR LINER 56MM
• 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: 17683136
• MDR Text Key: 322635968
• Report Number: 3005975929-2023-00125
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010596123
• UDI-Public: 3596010596123
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: 71335856
• Device Lot Number: 08GW17902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/03/2023
• 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: BHR MODULAR HEAD 44MM, LOT#08FW17446.; MODULAR SLEEVE -4MM 12/14, LOT#:08CW16005.; R3 3 HOLE ACET SHELL 56MM, LOT#:07LM04177.; SYN POR HO FEM COM SZ 14, LOT#:07CM21740.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male