MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD; PRSTHSSHPSMICNSTRINDUNCMNTDMTALPLYMRPROUS

Model Number	71338681
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to insert dislocation.The removed poly was labeled as a 60, but when removing it read as a 58.Surgeon checked again to make sure the poly engaged in the cup and it did, so he opened up a 60 constrained r3 liner which also engaged in the readapt cup.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The laser etching on the device is incorrect; it read size 58 instead of 60.The device has signs of damage from insertion/ extraction.The device was manufactured in 2019.The clinical / medical investigation concluded that, it cannot be ruled out, but the patient¿s non-compliance with discharge instructions likely contributed to the dislocation that subsequently lead to a revision.However, the reported issue was confirmed by the product evaluation, the laser etching on the device is incorrect; it read size 58 instead of 60.The future impact to the patient beyond the revision cannot be determined.The finding of the incorrect labeling on the device was incidental and did not contribute to dislocation and revision that resulted.No further clinical assessment is warranted at this time.The dimensional evaluation found the device to be within specification; only the laser marking is incorrect.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause of the reported event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD
• Common Device Name: PRSTHSSHPSMICNSTRINDUNCMNTDMTALPLYMRPROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9558127
• Report Number: 1020279-2020-00151
• Device Sequence Number: 11523825
• Product Code: MBL
• UDI-Device Identifier: 00885556113233
• UDI-Public: 00885556113233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 71338681
• Device Catalogue Number: 71338681
• Device Lot Number: 19HM21059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/17/2020
• 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