MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVD MONO STEM 300MM SZ 16 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	71354858
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Pain (1994); Local Reaction (2035); Ambulation or Postural Difficulties (2544)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that after a medically indicated revision of right total hip, performed on (b)(6) 2017, where redapt slvd mono stem 300mm sz 16 ho was implanted, the patient experienced cellulitis, which was treated with antibiotics.2 months postop, some induration was noticed above anterior portion of hip.Last follow up, 8 months after surgery reported groin pain and walking with assistance device.The outcome of the patient is unknown.Additional details about primary surgery are unknown.Patient outcome is unknown.This de-identified clinical data is related to a post market clinical follow-up activity for redapt sleeved mono stems.As the data collection activity has been done retrospectively and data is provided anonymized, the information provided is limited and further information cannot be obtained.
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, per case details, after an unknown primary surgery and right total hip revision, the patient experienced cellulitis, which was treated with antibiotics and 2 months postop, some induration was noticed above anterior portion of hip.Also reported was groin pain and an assistive device for walking.The area of cellulitis is unspecified.It has been reported that no additional information is available.No further patient specific clinically relevant information was provided for evaluation.Without clinically relevant information for evaluation, the root cause of the reported events cannot be definitively concluded.Further patient impact beyond the reported symptoms including infection pain¿ could not be assessed.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed device.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 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: REDAPT SLVD MONO STEM 300MM SZ 16 HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12523513
• Report Number: 1020279-2021-07102
• Device Sequence Number: 16422272
• Product Code: MEH
• UDI-Device Identifier: 00885556580424
• UDI-Public: 00885556580424
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 71354858
• Device Catalogue Number: 71354858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/03/2021
• 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
• Patient Age: 83 YR