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

Model Number	71337648
Medical Device Problem Codes	Positioning Failure (1158); Fitting Problem (2183)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tha surgery, after implanting the r3 outer cup, the 32mm x 48mm r3 20 degree xlpe acetabular liner could not be implanted.The procedure was concluded with a 50 mm liner from smith and nephew.Surgery was delayed less than 30 min.The patient was not harmed.
Additional Manufacturer Narrative
It was reported that during a tha surgery, after implanting the 48 mm r3 outer cup, the liner couldn't be implanted.Procedure was concluded with backup devices from smith and nephew, a 50 mm cup and a 50 mm liner.No additional bone cuts or any injury and a delay of less than 30 minutes were reported.The affected r3 acetabular liner, intended for use in treatment, was returned and evaluated.A visual inspection of the device shows signs of damage, probably from attempted use.Our quality team completed dimensional analysis on the returned product and noted that all measured features are within tolerance per associated drawing print.At this time, the cause of the complaint cannot be contributed to the dimensions of the returned product.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.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.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no further clinical assessment is warranted.Some potential causes of the reported event could include but are not limited to surgical technique used, size of device or user/procedural variance.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.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• 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: 10171115
• Report Number: 1020279-2020-02539
• Device Sequence Number: 11288172
• Product Code: JDI
• 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): 03/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71337648
• Device Catalogue Number: 71337648
• Device Lot Number: 19FM16587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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: Required Intervention
• Patient Age: 77 YR