MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	71331752
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after two dislocation episodes (one getting out of low recliner and the second bent over with leg flexed to reach foot), a revision surgery was performed to change femoral head and liner to a constrained liner.
Additional Manufacturer Narrative
The associated biolox delta head and r3 delta ceramic liner were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed parts including the ring with the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.However, the supplier of the devices will be informed about this issue.Our clinical evaluation noted that from one of the two undated x-ray photos, the reason for the dislocation cannot be concluded as the angle of inclination cannot be confirmed based on this image but it is not estimated to be extreme.Due to the dislocations a revision surgery was performed a little less than one month post op.The previous incision was used to open the joint, the joint was found stable.The information provided by the sales representative did not indicate a dislocation was observed during the revision.The head and liner were removed and appropriate size constrained liner and head were inserted.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported dislocations cannot be determined.No further clinical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reevaluated.We consider this investigation closed.

• Brand Name: R3 36MM ID INTL DLT CER LNR 52MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8063963
• Report Number: 1020279-2018-02441
• Device Sequence Number: 2462432
• Product Code: JDH
• UDI-Device Identifier: 03596010566959
• UDI-Public: 03596010566959
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71331752
• Device Lot Number: 17LT95066
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER :76539165/LOT NUMBER :18DT02263; PART NUMBER :76539165/LOT NUMBER :18DT02263
• Outcome Attributed to Adverse Event: Other; Required Intervention