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 Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during thr surgery, the cup did not match in the liner.The procedure was completed without delay and backup from smith&nephew was available to finished the procedure.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that during thr surgery, the cup did not match in the liner.The procedure was completed without delay with another liner from smith and nephew.The affected complaint device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned part shows no obvious damage on the part.A dimensional was evaluated for critical design features.All measured features were within tolerance.At this time, the failure mode in the complaint could not be confirmed as relating to the part's manufactured features.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch 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 device and the reported incident could not be corroborated.Some potential causes of the reported event could include but are not limited to size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
It was reported that during thr surgery, the cup did not match in the liner.The procedure was completed without delay with another liner from smith and nephew.The affected complaint device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned part shows no obvious damage on the part.A dimensional was evaluated for critical design features.All measured features were within tolerance.At this time, the failure mode in the complaint could not be confirmed as relating to the part's manufactured features.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch 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 device and the reported incident could not be corroborated.A clinical evaluation noted that the root cause of the reported event could not be definitively concluded, although a user/procedural technique could not be ruled out as a potential contributing factor.Per the surgical technique, tabs must align with the indentions in the cup and requires firm impaction.Of note, the locking mechanism does not support more than one repositioning of the liner.The patient impact beyond the reported 0-30 minute surgical extension could not be determined, as it was reported that the procedure was successfully completed using a same size/backup device and the patient status was ¿ok¿.No further medical assessment could be rendered at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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: 10422770
• Report Number: 1020279-2020-04014
• Device Sequence Number: 2990950
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71337648
• Device Catalogue Number: 71337648
• Device Lot Number: 19GM04473
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/25/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 04/22/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 01/13/2021; 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1