MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLY, POROUS

Model Number	71331856
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/11/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to luxation of the cup.Explanted devices: r3 cup, r3 liner and competitor head.In addition, this patient underwent two closed reductions due to previous luxations on (b)(6) 2011 and (b)(6) 2011.
Additional Manufacturer Narrative
It was reported that the patient underwent a revision surgery due to luxation of the cup.The affected r3 no hole coated shell, r3 acetabular insert and hole cover, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products 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.Medical analysis noted that based solely on the translation of the provided operative reports and poor quality images, it is not possible to determine or confirm proper positioning of the implant, or whether the patient had any underlying comorbidities which may have been a contributing factor to the reported dislocations and revision.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 0 HOLE ACET SHELL 56MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9700497
• Report Number: 1020279-2020-00523
• Device Sequence Number: 16850145
• Product Code: MBL
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: No Information
• Device Expiration Date: 09/27/2020
• Device Model Number: 71331856
• Device Catalogue Number: 71331856
• Device Lot Number: 10JM20656
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71330001 / 10DM17328; 71335756 / 10HM13862; 71330001 / 10DM17328; 71335756 / 10HM13862
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention