MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71338663
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr procedure, patient presented protracted wound healing.Medication therapy and prolonged hospitalization were necessary to treat this problem.Implants remained in place.
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, report form/crfs documented a wound healing delay occurred which required a 1-day hospitalization with unspecified medication therapy.Findings were reported as ¿mrse was detected in culture test¿.The crf documentation ((b)(6) 2018) recorded the first adverse event as recovering/resolving.Of note, the patient ¿was scheduled for surgery and developed pharyngitis and surgery was canceled¿.Reportedly, the left hip components remained in vivo per the (b)(6) 2018 serious adverse event report form without indication of further complications.Although the reported positive culture test could not be ruled out as a contributing factor to the protracted wound healing, the definitive root cause could not be concluded.Based on the information provided in the study forms, the patient impact beyond the reported hospitalization due to the delayed wound healing, surgery cancellation (secondary to pharyngitis) and medication therapy could not be determined.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 not limited to 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 MULTI HOLE ACETABULAR SHELL 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10815819
• Report Number: 1020279-2020-06339
• Device Sequence Number: 13921297
• Product Code: MBL
• UDI-Device Identifier: 00885556021941
• UDI-Public: 00885556021941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71338663
• Device Catalogue Number: 71338663
• Device Lot Number: 18AW07960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 08/26/2021
• 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: INSERT 71339548, LOT 18CM118297; INSERT 71339548, LOT 18CM118297
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 63