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

Catalog Number UNKNOWN

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

Patient Problem Bone Fracture(s) (1870)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Article: kato, s., nozawa, m., kim, s., sakamoto, y., ochi, h., & ishijima, m.(2022).Comparison of the 5-year outcomes between standard and short fit-and-fill stems in japanese populations.Arthroplasty today, 15, 108-114.Doi: https://doi.Org/10.1016/j.Artd.2022.03.023.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.

Event Description

It was reported that on literature review "comparison of the 5-year outcomes between standard and short fit-and-fill stems in japanese populations", 2 (two) patients (1 in the standard-stem group and 1 in the short-stem group) had a postoperative fracture, after a tha procedure using a synergy hip stem.The event was treated with internal fixation operation using a periprosthetic femoral fracture plate.Health status of the patients is unknown.No further information is available.

Manufacturer Narrative

H10: additional information has been received from the corresponding author of this publication.Further details regarding patient specific information were provided.Please refer to the enclosed assessment spreadsheet with contains the most recent version of the quality records initiated/updated based on the author's response.

Event Description

It was reported that on literature review "comparison of the 5-year outcomes between standard and short fit-and-fill stems in japanese populations",1 (one) patient had a postoperative fracture, after a tha procedure using a synergy hip stem performed on (b)(6) 2012 on the left hip.The event was treated with internal fixation operation using a periprosthetic femoral fracture plate.Health status of the patients is unknown.No further information is available.

• Brand Name: UNKNOWN SYNERGY HIP STEM
• 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: 18320049
• MDR Text Key: 330396601
• Report Number: 1020279-2023-02496
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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: 12/12/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/15/2024
• 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: 19 YR
• Patient Sex: Male