MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71337648
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery after the cup was implanted, a 48/32 liner was not fitting with a 48/32 cup (smaller).A backup liner was used along with additional bone cuts in order to complete the surgery.No was delay reported.
Additional Manufacturer Narrative
The associated device used in treatment was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted insertion.The device was manufactured in 2019.The medical investigation concluded, that photos of the product and the packing box have been provided for review, and confirms the size reported.Although it was reported, that additional bone cuts were needed to complete the procedure, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Without the requested clinical information, a thorough medical investigation cannot be rendered.The patient's current condition is unknown.Should any additional clinical information be provided, this complaint will be re-evaluated.A dimensional inspection of the mating features on the device found them to be within specification.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include improper surgical technique or a sizing/ fit issue.Based on this investigation, the need for corrective action is not 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 20 DEG XLPE ACET LNR 32MM X 48MM
• 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: 9965191
• Report Number: 1020279-2020-01308
• Device Sequence Number: 2718721
• Product Code: MBL
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 71337648
• Device Catalogue Number: 71337648
• Device Lot Number: 19DM11399
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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: Required Intervention
• Patient Age: 76 YR