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 Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 08/18/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed due to a pseudotumor.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the r3 liner, hemi head & modular sleeve were removed.The r3 shell & 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.All the released devices involved met manufacturing specifications at the time of production.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 revision intraoperative report indicated the presence of a large bloated capsule, which upon incision of the capsule, approximately 200 cc of tancoloured fluid was encountered.The components of the fluid were sent for cultures and gram stain.The cyst wall was with a grayish discoloration of the wall.There was slight grayish material between the liner and the actual shell.This was gathered and sent for cultures.Although it was reported the patient had a spontaneous dislocation while rising out of a chair, the root cause cannot be determined but the orientation of the cup cannot be ruled out as the anteversion is reported as 30 degrees.Without the supporting lab results, imaging, and the analysis of the explanted components, the root cause of the reported pain, grayish material and pseudotumor cannot be confirmed and it cannot be concluded if the reported position of the cup played a role.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Further, it cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.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.Additional information:age or date of birth, relevant tests/laboratory data, other relevant history, brand name, concomitant medical products anddevice manufacture date.

• 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: 8226389
• MDR Text Key: 132363555
• Report Number: 3005975929-2019-00009
• 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
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2018
• Device Catalogue Number: 71341158
• Device Lot Number: 08FW17405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122546/ UNKNOWN; HOLE ACET SHELL 71331858/ UNKNOWN; MODULAR SLEEVE 74222300/ UNKNOWN; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR