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

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 10/29/2022

Event Type  Injury  

Event Description

It was reported that on literature review "similarly low blood metal ion levels at 10-years follow-up of total hip arthroplasties with oxinium, cocrmo, and stainless steel femoral heads.Data from a randomized clinical trial", 1 patient had aseptic loosening after a thr procedure using a reflection all-poly highly cross linked polyethylene.The event was treated with revision surgery.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

Article: høl, p.J., hallan, g., furnes, o., fenstad, a.M., indrekvam, k., & kadar, t.(2023).Similarly low blood metal ion levels at 10-years follow-up of total hip arthroplasties with oxinium, cocrmo, and stainless steel femoral heads.Data from a randomized clinical trial.Journal of biomedical materials research part b: applied biomaterials, 111(4), 821-828.Doi: 10.1002/jbm.B.35193.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.

Manufacturer Narrative

Internal complaint reference number: (b)(4).Section h6 (health effect - clinical code) was corrected.

• Brand Name: UNKNOWN REFLECTION ALL-POLY 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: 18304184
• MDR Text Key: 330221556
• Report Number: 1020279-2023-02479
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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: Not provided
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/12/2024
• 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