MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DM XLPE INSERT 22/36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71358213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was taken out due to an unknown adverse tissue reaction.Procedure was completed with a competitor device.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.According to clinical/medical investigation, this complaint from the united states reports that a dual mobility insert was removed and replaced with a competitor¿ liner secondary to ¿an adverse tissue reaction¿.After several attempts no information has been forthcoming.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and instructions for use found that the reported failure was documented appropriately.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OR3O DM XLPE INSERT 22/36
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10261032
• Report Number: 1020279-2020-03087
• Device Sequence Number: 2485406
• Product Code: LPH
• UDI-Device Identifier: 00885556712337
• UDI-Public: 00885556712337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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 Model Number: 71358213
• Device Catalogue Number: 71358213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 05/10/2021
• 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