MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341154

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/05/2016

Event Type  Injury  

Event Description

Left hip revision surgery was performed due to pain and other complications.Surgeon's notes reportedly stated "failed left thr secondary to mom pseudotumour".

Manufacturer Narrative

T was reported that left hip revision surgery was performed due to pain and other complications.During the revision the hemi head, modular sleeve, emperion stem and r3 liner were removed.The r3 shell, emperion spout and screw remain implanted.As of today, device return and additional information has been requested for this complaint but has not become available.Using the supplied implantation dates, hospital name and implanting surgeon's name, the devices part numbers involved in this case have been preliminarily identified (subject to confirmation with medical records).The devices identified were as follows: 71341154, lot 09bw22130 r3 cocr liner; 71335554, lot 10hm08718 r3 shell; 74122542, lot 08lw14011 hemi head; 74222200, lot 10bw26770 modular sleeve; 71291301, lot 10em10071 emperion stem; 71291667, lot 09bab0048a emperion spout; 71332540, lot 10gm11877 screw.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.The available medical documents were reviewed.This case re-opened due to the receipt of medical documents i.E.Primary and revision operative report.It was reported six years post implantation of a ltha, this 70-year old female underwent a revision due to pain and other complications.Surgeon's notes reportedly stated "failed left thr secondary to mom psuedotumor".Intra-operative findings; a large amount of serous fluid was encountered upon entering the deep fascia, samples of the fluid was sent for gram stain and culture.The patient's abductor attachments of the trochanter were normal and there was no soft tissue damage.Additionally, there was no deep metallic staining or signs of osteolysis.The sleeve was well fixed and the cup were well fixed in good position.Biopsies from the synovium and capsule were sent for alval.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left 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 shell, r3 liner, hemi head, sleeve, stem and stem spout slot was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the r3 shell, r3 liner, stem and stem spout slot.Similar complaints have been identified for the hemi head and sleeve.This failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided is consistent with reactions from metal debris.However, the source cannot be confirmed, neither the pathology report nor the metal ion levels were provided.Additionally, the patient¿s history of morbid obesity cannot be ruled out as a contributing factor.Therefore, it cannot be concluded whether the reported clinical reactions are associated the implant.The future impact to the patient beyond the revision cannot be concluded.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 COCR LINER 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6577649
• MDR Text Key: 75502496
• Report Number: 3005975929-2017-00096
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 71341154
• Device Lot Number: 09BW22130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2017
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71335554, LOT # 10HM08718; CONE SPOUT, # 71291667, LOT # 09BAB0048A; FEMORAL STEM, # 71291301, LOT # 10EM10071; HEMI HEAD, # 74122542, LOT # 08LW14011; MODULAR SLEEVE, # 74222200, LOT # 10BW25770; SPHERICAL SCREW, # 71332540, LOT # 10GM11877; ACETABULAR SHELL, # 71335554, LOT # 10HM08718; CONE SPOUT, # 71291667, LOT # 09BAB0048A; FEMORAL STEM, # 71291301, LOT # 10EM10071; HEMI HEAD, # 74122542, LOT # 08LW14011; MODULAR SLEEVE, # 74222200, LOT # 10BW25770; SPHERICAL SCREW, # 71332540, LOT # 10GM11877
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR