MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 46MM ID US COCR LNR 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Joint Swelling (2356); Test Result (2695); No Code Available (3191)

Event Date 05/08/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, popping, grinding of implant and elevated metal levels.Bilateral patient with left hip devices still implanted.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, popping, grinding of implant and elevated metal levels.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

It was reported that right hip revision surgery was performed.During the revision, the r3 liner, hemi head and modular sleeve were removed.The r3 shell and anthology 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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s multiple falls had on his pain and clinical status.The pain, elevated metal ions, effusion, atrophy and trunnionosis are consistent with findings associated with metallosis, however; the root cause of the reported reactions cannot be determined and it cannot be concluded that the 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 46MM ID US COCR LNR 58MM
• 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: 7628546
• MDR Text Key: 111979533
• Report Number: 3005975929-2018-00233
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 71341158
• Device Lot Number: 09CW22761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, PART AND LOT # UNKNOWN; HEAD 74122546, LOT 09CW20680; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; SLEEVE 74222200, LOT 09GW24202; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention