MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 42MM ID US COCR LNR 54MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71341154

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

''us legal mdl'': it was reported that after a right r3-tha construct was implanted on (b)(6) 2009, plaintiff experienced pain, stiffness, loss of mobility, and metallosis.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During the surgery a new liner and oxinium head were implanted.Additional details about the surgery are unknown.Plaintiff outcome is unknown.

Manufacturer Narrative

Additional information: a2, a3, b5, d1, d4, d5, d10, e1, g1 phone number, g2, h4, h6.

Event Description

*us legal mdl* it was reported that after a right r3-tha construct was implanted on (b)(6) 2009, plaintiff experienced pain, stiffness, loss of mobility, and metallosis.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During the surgery osteolysis around the proximal femur and inferior acetabulum was found.A new liner and oxinium head were implanted.Plaintiff outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 liner, hemi head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints have been identified for the r3 liner and hemi head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.A review of the historical complaint data for the r3 liner, hemi head and sleeve was performed using related reported failures and the part number for the prior 12 months as of the complaint aware date.No other similar complaints have been identified for the r3 liner and sleeve.Similar complaints have been identified for the hemi head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.All the released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.R3 liner, hemi head and sleeve 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.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion.However, the implantation operative report indicated the hip was placed at about 10 degrees of anteversion.It is unknown if the decreased anteversion of the acetabular component led to accelerated wear and the reported ¿pain, stiffness, loss of mobility, and metallosis¿ and intraoperative findings of osteolysis.Based on the information provided, the clinical root cause of the reported events cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, loss of mobility, stiffness, revision, and expected transient post-op convalescence period cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this 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 and preventative actions is not indicated.

• Brand Name: R3 42MM ID US COCR LNR 54MM
• 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: 12546110
• MDR Text Key: 273750421
• Report Number: 3005975929-2021-00451
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2018
• Device Catalogue Number: 71341154
• Device Lot Number: 08MW20481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 71306114 / 09CM05566; 71335554 / 09AM10780; 74222300 / 08EW16970
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Male