MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC

Model Number 71338954

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, patient underwent bilateral thr ((b)(6) 2011).Underwent revision of right side ((b)(6) 2014) for failed ceramic liner noted after felt unusual movement while playing tennis and, while not apparent on x-rays, was confirmed by arthrogram ct.The fractured liner was replaced with smith & nephew back up devices.It is unknown if there was a surgical delay.No other complications where reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The lab analysis concluded that the intact 36mm forte ceramic head shows signs of titanium transfer on the articulating surface.This transfer could have been cause by having femoral head contacting the edge of the acetabular shell or the compressive ring on the liner.The ceramic liner fractured below the distal end of the compressive ring.To have a clear image of the fractured surface, the part was sputter gold coated for sem observation.The images provided from the fractured surface indicating the slow fracture with beach marks could have initiated.Most of the fractured surfaces are smooth with little to no features (fast fracture rate).The cause of the ceramic liner fracture could not be determined with certainty.The clinical/medical evaluation concluded that this case reported via medwatch, states that a biolox ceramic head and r3 liner were revised on the right hip approximately 2 and a half years post implantation, after an unusual movement was noted while playing tennis.The fractured liner was reported to be confirmed by arthrogram ct, but not apparent on x-rays.The requested medical/surgical records and radiographs have not been provided.Therefore, the patient impact beyond the revision, and the clinical root cause of the fracture cannot be determined.Due to the lack of information provided, a clinical assessment cannot be rendered.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC
• 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: 11256854
• MDR Text Key: 229576506
• Report Number: 1020279-2021-00796
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556021927
• UDI-Public: 00885556021927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

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 Model Number: 71338954
• Device Catalogue Number: 71338954
• Device Lot Number: 09GT33613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71309111/SYN POR PLUS HA HO STEM SZ 11/10JM02989; 71331854/R3 0 HOLE ACET SHELL 54MM/10MM03802; 71336500/REF THREADED HOLE COVER/10LM10193; UNKNOWN FEMORAL HEAD IMPLANT; 71309111/SYN POR PLUS HA HO STEM SZ 11/10JM02989; 71331854/R3 0 HOLE ACET SHELL 54MM/10MM03802; 71336500/REF THREADED HOLE COVER/10LM10193; UNKNOWN FEMORAL HEAD IMPLANT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 117 KG