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

Catalog Number UNKN01100907

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 08/23/2010

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6) it was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s left hip on (b)(6) -2010, the plaintiff has been experiencing high levels of cobalt and chromium in blood, intense pain and ambulatory difficulties.A revision surgery has been medically indicated, but still not conducted due to a current waiting list of 12-18 months.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, post operative complications, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

It was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s left hip on (b)(6) 2010, the plaintiff has been experiencing high levels of cobalt and chromium in blood, intense pain and ambulatory difficulties.A revision surgery was performed on (b)(6) 2022 in which the oxinium femoral component and the polyethylene acetabular component were removed.Also, pseudotumor excision with collection of brownish tissue that sits over the synovium inside the capsule and osteolysis with brownish material at the proximal portion of the femur with a vacuum around the anterior proximal aspect of the femoral stem with no signs of looseness.Stability and range of motion were tested with a satisfactory result.No other complications were reported.

Manufacturer Narrative

H3, h6: it was reported that a patient has been experiencing high levels of cobalt and chromium in blood, intense pain and ambulatory difficulties.A revision surgery was performed in which the oxinium femoral component and the polyethylene acetabular component were removed.Also, pseudotumor excision with collection of brownish tissue that sits over the synovium inside the capsule and osteolysis with brownish material at the proximal portion of the femur with a vacuum around the anterior proximal aspect of the femoral stem with no signs of looseness.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the unkn r3 metal liner impl.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 for all modular head and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Although the reported pain, elevated metal ions, pseudotumor, osteolysis and brownish tissue are consistent with the pathology report of ¿alval metallosis¿ the clinical root cause cannot be definitively concluded.It cannot be concluded the reported events were associated with a mal performance of the implant or implant failure.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 device 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, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12519720
• MDR Text Key: 272925982
• Report Number: 1020279-2021-07093
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2023
• 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.; UNKN ORTHOPAEDIC RECONSTRUCTION DEV.; UNKN R3 SHELL.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male