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

Model Number	71335752
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure tka, the cup was miss fit (inside the patient).The procedure had a delay between 0-30 min.The patient presented an unspecified injury.The procedure was finished with a backup from smith&nephew.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Results of investigation: it was reported that during procedure tka, the cup is miss fit (the incident occurs inside the patient).The procedure had a delay between 0-30 min.The procedure was finished with a backup from smith and nephew.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Potential causes could include but not limited to size of device, surgical technique used, user/procedural variance or unclear user instructions.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10230290
• Report Number: 1020279-2020-02902
• Device Sequence Number: 3142986
• Product Code: JDI
• UDI-Device Identifier: 03596010598332
• UDI-Public: 03596010598332
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71335752
• Device Catalogue Number: 71335752
• Device Lot Number: 19MM11288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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