MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,

Catalog Number 71338952

Device Problems Break (1069); Fracture (1260)

Patient Problems Ossification (1428); Cellulitis (1768); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case: (b)(4).

Event Description

It was reported that, patient underwent bilateral thr ((b)(6) 2011).On (b)(6) 2020 a revision surgery due to pain in the left hip after playing golf was performed.A ct scan showed a fracture of the r3 ceramic liner.The following devices where explanted: r3 ceramic liner, r3¿ no hole acetabular shell, synergy porous plus stem , unknown femoral head insert and r3¿/reflection¿ threaded hole cover.The procedure was completed with smith & nephew back-up devices.It is unknown if there was a surgical delay.After surgery and once patient discharged home ((b)(6) 2020), in december the patient developed an area of cellulitis at the distal incision, treated with antibiotics.As of ((b)(6) 2021) office visit, there was improvement in the cellulitis; there was no obvious fluid collection and the skin & subcutaneous tissues felt normal.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

G3, h2, h3, and h6: the associated device, used in treatment, 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 caused 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.The fractured surface indicated a slow fracture with beach marks.Most of the fractured surfaces are smooth with little to no features.The cause of the ceramic liner fracture could not be determined with certainty.The clinical/medical evaluation concluded that based on the documentation provided, the root cause of the reported revision secondary to liner disruption could not be definitively concluded.However, it is unknown if the patient activity and/or the reported ¿proliferative bony remodeling¿/ectopic bone formation on the left greater¿ trochanteric area since 2016 could have contributed to the reported event.The patient impact beyond the reported symptoms, clinical findings and revision procedure could not be determined.It was reported that 6 weeks post-revision the hip was aligned with improvement of the post-revision cellulitis after antibiotic therapy.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal an additional complaint for the listed batch for the same failure mode.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 and potential harm was previously identified.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 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11250345
• MDR Text Key: 229298348
• Report Number: 1020279-2021-00772
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556021552
• UDI-Public: 885556021552
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 71338952
• Device Lot Number: 09CT29209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309111/SYN POR PLUS HA HO STEM SZ 11/10JM02989.; 71331852/R3 0 HOLE ACET SHELL 52MM/11AM00537.; 71336500/REF THREADED HOLE COVER/10LM10193.; UNKNOWN FEMORAL HEAD IMPLANT.; 71309111/SYN POR PLUS HA HO STEM SZ 11/10JM02989; 71331852/R3 0 HOLE ACET SHELL 52MM/11AM00537; 71336500/REF THREADED HOLE COVER/10LM10193; UNKNOWN FEMORAL HEAD IMPLANT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 117