LINK Instrument 136-115/00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575182091), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (K183141); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 3, 2023Open, Classified

   Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

   Z-2346-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  DR. (B)(6) WAS PERFORMING A MP MONOBLOCK HIP SURGERY ON (B)(6) 2023 AND WAS TRIALING WITH A SIZE 15 TRIAL STEM AND 195 LATERIAL TRIAL NECK AND HAD A DIFFICULT TIME REMOVING THE TRIAL. IT DID EVENTUALLY COME OUT AFTER 10 TO 15 MINUTES OF TRYING, USING EXTRACTOR AND SLAP HAMMER. THE DOCTOR MENTIONED THAT THIS IS VERY COMMON WITH THE SIZE 15 TRIAL. WAITING INFORMATION ON WHETHER TRIALS CAN BE SENT FOR INVESTIGATION. UPDATED 20230511: IMAGES AND LOT CODES UPDATED. REPRESENTATIVE WHO REPORTED EVENT RESPONDED THAT THE INSTRUMENTS ARE NOT BROKEN AND ARE NEEDED IN THE SET SO THEY WILL NOT BE SENT BACK, IT WAS REPORTED BECAUSE OF THE DIFFICULTY OF USE, WHICH HE STATED WAS COMMON FOR THE SIZE 15 TRIAL. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17496584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183141. One submission often covers many models, so check the product and lot details in each record.

• Z-2347-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2348-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2354-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2353-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2356-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2349-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2355-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2351-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2352-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2345-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Nu
• Z-2350-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Num