MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71337660
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an unspecified surgery, it was impossible to impact the 20 deg xlpe acet lnr 32mm x 60mm on the patient correctly.To solve this, 36 polyethylene was placed, which impacted without problem.The procedure was completed with a less than or equal to 30 mins delay using a smith and nephew back-up device.No other complications were 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.A dimensional evaluation of the returned device could not confirm the stated failure.All measured features are within tolerance per associated drawing print.See attachment for dimensional inspection report.The cause of the complaint cannot be contributed to the dimensions of the returned product.The clinical/medical evaluation concluded that this case reports the r3 liner would not impact correctly.The procedure was completed using a backup device with a surgical delay of less than 30 minutes and no injury to the patient.Therefore, no further clinical assessment is warranted.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 and potential harm was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11587197
• Report Number: 1020279-2021-02478
• Device Sequence Number: 17189033
• Product Code: MBL
• UDI-Device Identifier: 03596010598530
• UDI-Public: 03596010598530
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2021

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 Expiration Date: 04/03/2022
• Device Model Number: 71337660
• Device Catalogue Number: 71337660
• Device Lot Number: 12DM03699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 08/15/2021
• 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; Other; Required Intervention