MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 48MM ID US COCR LNR MM60; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341160

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Toxicity (2333); Injury (2348); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 08/07/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis; elevated cobalt and chromium levels; pseudotumor; multiple dislocations.Subsequent revision of unknown parts (b)(6) 2017.Previous mdr was submitted for the same patient due to left hip revision.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metallosis; elevated cobalt and chromium levels; pseudotumor; multiple dislocations.As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

This is bilateral complaint.It was reported that right hip revision surgery was performed due to metallosis, elevated cobalt and chromium levels, pseudotumor and multiple dislocations.During revision, the r3 liner and bhr resurfacing head were removed, alongside the remaining r3 shell.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.The right side revision (both occurred before the left revision) operative notes document; ¿there was moderate synovitis of the right hip present.The backside of the acetabular metal liner was marked grain of soft tissue indicating this was the primary area of micromotion and metal debris.¿ metal ion levels were provided ¿ the first set was prior to the right side revision = cobalt: 5.0 ng/ml high [<3.0] chromium: 9.1mcg/l high [0.1-2.01].The second set was just before the left side revision = cobalt 1.8 ng/l [<3.0] chromium: 3.7 mcg/l high [0.1-2.1].They were definitely lower than the first set but still elevated.The clinical information provided, (c-210409 c-201410) the elevated metal ion levels, synovitis and staining may be consistent with a reaction to metal debris.However the source cannot be determined with the available documentation.Also, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The components revised were the bhr resurfacing, the r3 liner and r3 shell.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 48MM ID US COCR LNR MM60
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7664580
• MDR Text Key: 113254018
• Report Number: 3005975929-2018-00249
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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: 71341160
• Device Lot Number: 08MW20523
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71332530/09EM20546; 71335560/09CM03190; 71336500/09GM05286; 74123148/07JW13246; UNKNOWN BHR IMPLANT/ UNKNOWN LOT NUMBER; UNKNOWN BHR IMPLANT/ UNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR