MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71335756
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Impaired Healing (2378)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a thr surgery, one syn por fem comp sz 13, one r3 3 hole acet shell 56mm, one oxinium fem hd 12/14 36 mm -3, and one r3 20 deg xlpe acet lnr 36mm x 56mm were associated with a post-operative reaction (pain, infection and unhealed incision).This happened after use in patient.The issue was resolved with a revision surgery, in which the surgeon removed all the implants.Current health status of the patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports the patient complaint of pain, infection and unhealed incision after a thr surgery.A ¿revision¿ surgery was performed to explant all devices.The patient¿s current health status is unknown.No relevant supporting clinical information has been provided to assist with a clinical investigation.The root cause of the revision/component explants was most likely the reported infection; however, the root cause of the infection, pain and unhealed incision could not be definitively concluded.The patient impact beyond the reported events could not be determined.No further medical assessment is warranted.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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, joint tightness, patient reaction, contamination, patient reaction, and post-operative healing issue.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 20 DEG XLPE ACET LNR 36MM X 56MM
• 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: 12511046
• Report Number: 1020279-2021-07042
• Device Sequence Number: 3908311
• Product Code: JDI
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 71335756
• Device Catalogue Number: 71335756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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; Other; Required Intervention
• Patient Age: 65 YR