MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341152

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Tissue Damage (2104); Injury (2348); Joint Dislocation (2374); Test Result (2695)

Event Date 05/02/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.Recurring dislocation, metallosis, soft tissue destruction reported.Bilateral patient, right hip revision to be reported via subsequent mdr.Femoral stem remained implanted.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to recurring dislocation, metallosis and soft tissue destruction.During the revision the hemi head, r3 liner, r3 shell and modular sleeve were removed.The femoral stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.According to the provided revision report, the patient started having subluxations approximately 1 year before the revision, followed by dislocations weeks before the revision.A severe posterior instability, severe metallosis, soft tissue destruction (posterior capsule, abductor tendons, short rotators, part of posterior gluteus medius), metallosis and local reaction to metal were noted.The cup was reported to be well anchored in at least 75° inclination.Review of the provided implantation report did report that such a high inclination was chosen for implantation.The provided laboratory reports confirm the elevated serum chromium of 27.2g/l and blood cobalt of 63.7g/l with respect to the given reference ranges collected on the date of the first revision before the revision based on the time stamp.At this time a contra-lateral hip replacement was also present and could have partly contributed to these levels.The reason for the high cup inclination remains unclear.As it was well anchored, it is probably not a result of the reported findings but caused or contributed to them.However, without the device or xrays available for analysis further investigation of the factors leading to the revision cannot be performed.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.During the revision, the hemi head, r3 shell, r3 liner and modular sleeve were removed.The synergy stem remained implanted.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 head, cup, liner, shell and stem 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 head or stem.A similar complaint has been identified for the sleeve, r3 shell and r3 liner and 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.The available medical documents were reviewed.It cannot be determined to what extent the patients multiple dislocations of her left hip had on her pain and clinical status as well as the vertical orientation of the acetabular cup.The reported elevated cobalt and chromium as well as intraoperative findings of grey, black, oily fluid within the joint, erosion to the posterior capsule, short rotators and the gluteus medius may be consistent with findings of metal debris, however changes in position of the acetabular component could also accelerate wear and lead to metal debris.Without the supporting pathology results, imaging, and/or explanted components, the root cause of the vertical position of the acetabular component and metal debris cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 50MM
• 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: 7544040
• MDR Text Key: 109227740
• Report Number: 3005975929-2018-00178
• 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
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 71341152
• Device Lot Number: 08MW20478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71335552, LOT # 08LM00156.; FEMORAL STEM, # 71306612, LOT # 09DM11421.; HEMI HEAD, # 74122540, LOT # 07HW13126.; MODULAR SLEEVE, # 74222100, LOT # 08JW19026.; ACETABULAR SHELL, # 71335552, LOT # 08LM00156; FEMORAL STEM, # 71306612, LOT # 09DM11421; HEMI HEAD, # 74122540, LOT # 07HW13126; MODULAR SLEEVE, # 74222100, LOT # 08JW19026
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR