MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN POLARCUP PLASTIC INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Dislocation (2374)

Event Date 01/30/2023

Event Type  Injury  

Event Description

It was reported that on literature review "the dome technique for managing massive anterosuperior medial acetabular bone loss in revision total hip arthroplasty: short-term outcomes", 1 patient had hip dislocation with interprostethic dissociation of dual mobility component 6 months after a revision total hip arthroplasty (tha) procedure using a cmented 49mm polarcup and a 49mmx28mm polar xlpe devices.The event was treated with an open reduction and exchanging the liner.Patient is doing well.No further information is available.

Manufacturer Narrative

H10: internal complaint reference: (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.Humphrey, t.J., baker, c.M., courtney, p.M., paprosky, w.G., bedair, h.S., sheth, n.P., & melnic, c.M.(2023).The dome technique for managing massive anterosuperior medial acetabular bone loss in revision total hip arthroplasty: short-term outcomes.Hip & pelvis, 35(2), 122.Doi.Org/10.5371/hp.2023.35.2.122.

• Brand Name: UNKNOWN POLARCUP PLASTIC INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18739713
• MDR Text Key: 335763500
• Report Number: 9613369-2024-00015
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

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: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/21/2024; 03/26/2024
• Supplement Dates FDA Received: 03/21/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 70 YR
• Patient Sex: Female