MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REDAPT ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

On the literature review "augmenting pathologic acetabular bone loss with photodynamic nails to support primary total hip arthroplasty", it was reported that, after undergoing primary total hip arthroplasty on an unknown date in which a 52mm redapt acetabular shell was implanted in conjunction with photodynamic nail (pdn) insertion and acetabular screw fixation, one (1) patient required a 90-day readmission due to aseptic superficial wound dehiscence.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.As of the date of this medical investigation, no clinically relevant supporting documentation has been provided.Therefore, there were no clinical factors found which would have contributed to the reported aseptic superficial wound dehiscence and subsequent 90-day readmission.The impact to the patient beyond the readmission cannot be determined with the limited information provided.No further clinical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should 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: UNKNOWN REDAPT ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17299675
• MDR Text Key: 318833678
• Report Number: 1020279-2023-01433
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN DUAL MOBILITY LINER; UNKNOWN PHOTODYNAMIC NAIL
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female