MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRI SO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312102
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on literature review "inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup" 188 months after a tha surgery, where an spectron ef stem and a reflection non-crosslinked all-polly cup were implanted, the patient underwent a revision surgery due to loosinng of the cup and the stem.The study determined that both the stem and the cup were worn, additionally pe, cr, co and zr particles were present in the periprosthetic tissue.Current health status of the patient is unknown.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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.
Additional Manufacturer Narrative
H10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.A response was received from the publication author, indicating that the polyethylene (pe) particles liberated by the cup's wear may have been the primary cause of the osteolysis in the femur, as well as the loosening of the stem.Therefore, the stem will be handled as a concomitant device under report number 1020279-2024-00158.
Event or Problem Description
It was reported that on literature review "inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup" 188 months after a tha surgery on (b)(6) 2003, where an spec ef pri so 12/14 sz 2, a cocr 12/14 fem head 28 + 8 and a reflection non-crosslinked all-polly cup were implanted; the patient underwent a revision surgery on (b)(6) 2019 due to loosening of the cup and the stem.The study determined that both the stem and the cup were worn, additionally pe, cr, co and zr particles were present in the periprosthetic tissue.The polyethylene wear from the reflection cup was an important factor leading to loosening of the stem and cup.Current health status of the patient is unknown.No further information is available.

• Brand Name: SPEC EF PRI SO 12/14 SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 18531935
• Report Number: 1020279-2024-00157
• Device Sequence Number: 20520827
• Product Code: JDI
• UDI-Device Identifier: 03596010195524
• UDI-Public: 03596010195524
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71312102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG