MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71339550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2020, the patient experienced recurrent joint dislocations.The dislocations were caused by the oxinium fem hd 12/14 32mm +4 dislocating from the r3 0 deg xlpe acet lnr 32mm x 50mm.This adverse event led to a revision surgery performed on (b)(6) 2021, in which it was confirmed that the r3 3 hole ha ctd acet shell 50mm was well fixed and a severe scratch was noticed on the oxinium fem hd 12/14 32mm +4.The r3 0 deg xlpe acet lnr 32mm x 50mm and oxinium fem hd 12/14 32mm +4 were replaced, and as a consequence of that replacement, the r3 3 hole ha ctd acet shell 50mm had to be explanted.The current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation, the images provided were reviewed and the failure mode couldn't be confirmed.The clinical/medical investigation concluded that, based on the customer complaint form, the cup was well fixed.According to the sales rep., the patient had a spinal fusion a few months prior and the surgeon stated, ¿that is why the patient started to dislocate.¿ however, without the requested supporting clinical information a thorough medical investigation of the reported failure cannot be rendered.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this compliant would be re-assessed.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to traumatic injury, patient condition or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 50MM
• 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: 12311016
• Report Number: 1020279-2021-06304
• Device Sequence Number: 4585781
• Product Code: JDI
• UDI-Device Identifier: 03596010598806
• UDI-Public: 03596010598806
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 71339550
• Device Catalogue Number: 71339550
• Device Lot Number: 19JM01118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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; Required Intervention