MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338552
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to chronic dislocation of total hip.Liner component explanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.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 part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 36MM X 52MM
• 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: 8401316
• Report Number: 1020279-2019-00985
• Device Sequence Number: 2029649
• Product Code: MBL
• UDI-Device Identifier: 03596010598714
• UDI-Public: 03596010598714
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 71338552
• Device Lot Number: 16HM08934
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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: Hospitalization; Required Intervention