MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF INTERFIT ACET TH SZ 46; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336046
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a revision surgery where cup and liner were exchanged due to dislocation of the liner.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The reported complaint was for dislocation.From the analysis conducted in this investigation, observations of damage to the femoral head were found to be consistent with this reason for revision.Macroscopic examination showed scratches on the surface of the femoral head.Further material analysis revealed signs of damage to the oxide layer, signified by an elevated zirconium peak with an absence of an oxygen peak.An undamaged region was analyzed for comparison.This region revealed elevated peaks of both zirconium and oxygen, signifying an intact oxide layer.Material analysis of another scratched region revealed signs of material transfer, signified by elevated peaks of both titanium and aluminum.This finding suggests in-vivo contact between the femoral head and acetabular shell, which is consistent with dislocation.Additionally, bone on-growth and biological debris were observed on the acetabular shell.Discoloration was observed on the acetabular liner, as well as damage to the outer surface of the liner hood and liner rim.A review of the production documentation for the corresponding products 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 batches.The clinical/medical team concluded, the root cause for the revision is likely the dislocation.However, it is unknown if any trauma or accident occurred to contribute, or to cause the dislocation, and therefore the root cause of the dislocation of the liner cannot be concluded.The patient impact beyond the revision surgery cannot be concluded as there is no report of the patient¿s current condition or how the procedure was tolerated.No further clinical assessment is warranted.If new information is received in the future, this complaint can be re-opened.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The associated complaint devices were returned and evaluated.The lab analysis concluded, observations of damage to the femoral head were found to be consistent with this reason for revision.Macroscopic examination showed scratches on the surface of the femoral head.Further material analysis revealed signs of damage to the oxide layer, signified by an elevated zirconium peak with an absence of an oxygen peak.An undamaged region was analyzed for comparison.This region revealed elevated peaks of both zirconium and oxygen, signifying an intact oxide layer.Material analysis of another scratched region revealed signs of material transfer, signified by elevated peaks of both titanium and aluminum.This finding suggests in-vivo contact between the femoral head and acetabular shell, which is consistent with dislocation.Additionally, bone on-growth and biological debris were observed on the acetabular shell.Discoloration was observed on the acetabular liner, as well as damage to the outer surface of the liner hood and liner rim.A dimensional analysis concluded, the liner had features that could not be measured accurately due to damage that appeared to be from implantation attempts.The shell/hole cover and head were found to be within print specifications.The clinical/medical team concluded, the root cause for the revision is likely the dislocation.However, it is unknown if any trauma or accident occurred to contribute, or to cause the dislocation, and therefore the root cause of the dislocation of the liner cannot be concluded.The patient impact beyond the revision surgery cannot be concluded as there is no report of the patient's current condition or how the procedure was tolerated.No further clinical assessment is warranted.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: RF INTERFIT ACET TH SZ 46
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7174784
• Report Number: 1020279-2018-00036
• Device Sequence Number: 18847927
• Product Code: MBL
• UDI-Device Identifier: 03596010197511
• UDI-Public: 03596010197511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2018

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 Expiration Date: 03/21/2019
• Device Catalogue Number: 71336046
• Device Lot Number: 09CM17040
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 12/28/2017
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 04/24/2018; 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR