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

Catalog Number UNKN01100108

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.The reported events within the enclosed publication took place in several countries: united states, canada and united kingdom.A communication has been sent to the author to gather additional information on the occurrence and location of each event.However, at this time, we have not received a response from the corresponding author.Therefore, this report is being conservatively submitted as we cannot rule out the possibility that the event occurred in any of those countries.Berlinberg ej, kavian ja, roof ma, shichman i, frykberg b, lutes wb, schnaser ea, jones sa, mccalden rw, schwarzkopf r.Minimum 2-year outcomes of a novel 3d-printed fully porous titanium acetabular shell in revision total hip arthroplasty.Arthroplast today.2022 oct 12;18:39-44.Doi: 10.1016/j.Artd.2022.08.007.Pmid: 36267391; pmcid: pmc9576483.

Event Description

It was reported that on literature review "minimum 2-year outcomes of a novel 3d-printed fully porous titanium acetabular shell in revision total hip arthroplasty", 3 patients that sustained revision surgery and in which a redapt shells were implanted, required re-revision due to failure of osseointegration/aseptic loosening of the redapt shells after 15, 17, and 20 months respectively.Patient outcome is unknown.No further information is available.

• Brand Name: UNKN REDAPT ACET CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 17782779
• MDR Text Key: 323856769
• Report Number: 1020279-2023-01807
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2023

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: Lay User/Patient
• Device Catalogue Number: UNKN01100108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/20/2023
• 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
• Patient Outcome(s): Required Intervention