Peri-Loc 71800113Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010520098), received between Jan 14, 2019 and Feb 3, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K092015, K210837, K213126); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, 5 MONTHS AFTER RIGHT FEMUR INTERNAL FIXATION PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL. THEY WERE ABLE TO WALK THEREAFTER UNTIL THEY NOTICED SWELLING ON THE INJURED SITE. IT WAS LATER DISCOVERED THROUGH X-RAYS THAT THE 4.5MM LATERAL DISTAL FEMUR LOCKING PLATE WAS BROKEN. FRACTURE OF THE LATERAL PLATE ALONG WITH RE-FRACTURE OF THE FEMUR SHAFT WAS OBSERVED. THIS ADVERSE EVENT WAS TREATED WITH A REVISION ON (B)(6) 2023, IN WHICH A COMPETITOR'S PLATE (ZIMMER) WAS PLACED IN EXCHANGE. THE POST-REVISION OF THE INTERNAL FIXATION ALIGNMENT WAS DETERMINED TO BE SATISFACTORY.

  Patient problems: Hip Fracture; Swelling/ Edema

  MAUDE report 16297422 ↗
• InjuryApr 6, 2022Break; Fracture; Break; Fracture

  (B)(6) LEGAL: IT WAS REPORTED THAT, AFTER AN OPEN REPOSITIONING AND OSTEOSYNTHESIS SURGERY ON (B)(6) 2021 FOR A MULTIFRAGMENTARY PERIPROSTHETIC FRACTURE OF THE DISTAL FEMORAL PYRE IN THE RIGHT LEG, PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2021 BECAUSE AFTER GETTING UP FROM THE TOILET SUDDENLY PLAINTIFF NOTICED A "SNAPPING" AND THE RIGHT LEG DEFORMED INTO A 0 AND BECAME UNSTABLE. X-RAYS FOUND THAT THE PLATE HAD BROKEN IN THE MIDDLE, RESULTING IN A NEW FRACTURE OF THE THIGH BONE AT THE ORIGINAL LOCATION. PLAINTIFF SUFFERED FROM POSTOPERATIVE HEMORRHAGIC ANEMIA AND REQUIRED 2EKS TRANSFUSION TO STABILIZE HB. THE STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Anemia; Discomfort; Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 14018766 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 4.5MM L-D FEM LK PL13H R 286MM PLATE HAD BEEN IMPLANTED, THE FRACTURE WAS RADIOLOGICALLY SEEN AS DISPLACED AND NOT CONSOLIDATED. THERE WAS ALSO EVIDENCE OF SCREW BREAKAGE AND LOOSENING AT THE DISTAL PART. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ADVERSE EVENT. UPON PLATE EXTRACTION, IT WAS EVIDENT THAT ALL LOCKING SCREWS IN THE DISTAL AREA WERE LOOSE: THEY WERE NOT LOCKED IN THE PLATE. ALL HARDWARE WAS SUCCESSFULLY REMOVED AND REPLACED WITH AN INTERTAN NAIL. THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11479338 ↗
• InjuryNov 26, 2019Break; Break

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE THE PLATE HAS BROKEN ON THE PATIENT DURING NORMAL USE, THERE HAS NOT BEEN ANY ADDITIONAL INTERVENTION. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 9379251 ↗
• InjuryJan 14, 2019Break; Break

  IT WAS REPORTED THAT AN X-RAY SHOWED CALLUS FORMATION AND A PLATE BROKEN.

  Patient problems: Injury

  MAUDE report 8244502 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092015, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-2036-2017 · Mar 22, 2017 · Terminated
  PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116