REFLECTION, MICROSTABLE 71742850Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010232267), received between Jun 21, 2017 and Mar 8, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2005, THE PATIENT EXPERIENCED HIP INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2017, IN WHICH ONE (1) REF LNR 28X50-52 20 DEG SZ E WAS EXPLANTED AND REPLACED WITH A CONSTRAINED LINER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24542198 ↗
• InjuryJan 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2003, PATIENT PRESENTED AN UNKNOWN ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6)2023, IN WHICH LINER AND HEAD WERE EXCHANGED. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18426891 ↗
• InjuryNov 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON AN UNKNOWN DATE, MORE THAN 15 YEARS LATER THE REF LNR 28X50-52 20 DEG SZ E WORE OUT. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2023. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18166941 ↗
• InjurySep 5, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED LINER WEAR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A REF LNR 28X50-52 20 DEG SZ E WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17685038 ↗
• InjuryJun 11, 2022Degraded; Degraded

  IT WAS REPORTED THAT, AFTER A THR PROCEDURE HAD BEEN PERFORMED ON 2006, PATIENT EXPERIENCED WEAR FROM THE LINER. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY TO EXCHANGE THE REF LNR 28X50-52 20 DEG SZ E. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 14671956 ↗
• InjuryJan 3, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2001, THE PATIENT EXPERIENCED HIP PAIN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE REF LNR 28X50-52 20 DEG SZ E WAS FOUND WORN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Pain

  MAUDE report 13142242 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO A INFECTION, A POLY EXCHANGE WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11419435 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS. HEAD AND LINER EXPLANTED. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10577898 ↗
• InjurySep 21, 2020Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT DURING A RIGHT THR PROCEDURE, AFTER IMPLANTING THE OUT CUP 71336450 (REF THREE HOLE SHELL 50MM), LINER 71742850 (REF LNR 28X50-52 20 DEG SZ E) COULDN'T BE IMPLANTED. TRY TO USE THE LINER 71333324 (REF XLPE 28 20 DEG 50-52 E), STILL DIDN'T WORK. TRY TO USE THE OUT CUP OF 71336452 (REF THREE HOLE SHELL 52MM), STILL DID NOT WORK. DUE TO OSTEOPOROSIS OF THE PATIENT, THE OUTER CUP WAS LOOSE AND COULD NOT BE TIGHTENED MANY TIMES, RESULTING IN PARTIAL LOSS OF THE POSTERIOR WALL BONE. FINALLY, THE REINFORCE RING AND BONE CEMENT CUP WERE USED TO COMPLETE THE SURGERY. IN ADDITION, THERE WERE THE BONE GRAFT AND HERCULES BONE CEMENT TO PREVENT INFECTION. A DELAY GREATER THAN 30 MIN WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient; Osteopenia/ Osteoporosis

  MAUDE report 10564163 ↗
• MalfunctionAug 21, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE LINER CANNOT MATCH WITH THE ACETABULAR CUP. THEN THE COMPLAINT PRODUCT WAS TAKEN OUT AND A BACKUP WAS USED. A 30 MIN TO 1 HR DELAY WAS REPORTED. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8918538 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ECCENTRIC FEMORAL HEAD/POLYETHYLENE POSITIONING ON X-RAY AND RADIOGRAPHIC APPEARANCE OF OSTEOLYSIS IN PROXIMAL FEMORAL REGION. HEAD AND LINER REMOVED AND REPLACED WITH NEW PROSTHESIS.

  Patient problems: Injury

  MAUDE report 8560974 ↗
• InjuryDec 12, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE HEAD AND LINER DUE TO PAIN AND WEAR. LINER WAS LOOSE. DELAY OR LESS THAN 30MIN REPORTED. REPLACED WITH S&N IMPLANTS.

  Patient problems: Injury

  MAUDE report 8155518 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DOCTOR REMOVED HIP COMPONENTS DUE TO WEAR. DEVICE WAS IMPLANTED 12 YEARS AGO.

  Patient problems: Injury

  MAUDE report 7979481 ↗
• InjuryMay 2, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A 2 HOUR DELAY OCCURED DURING A TOTAL HIP REPLACEMENT DUE TO A REFLECTION LINER AND AN ACETABULAR CUP THAT COULD NOT BE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7480659 ↗
• InjuryOct 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT UNSPECIFIED MEDICAL INTERVENTIONS WERE PERFORMED DUE TO PATIENT BLOOD PRESSURE DROP AND INCREASED HEART RATE AT THE END OF THE SURGERY. THE PATIENT RETURNED TO STABLE CONDITION AND SENT TO PACU. THE SURGEON STATED THERE WAS A SURGICAL DELAY OF 30 MINUTES DUE TO THE LINER NOT LOCKING.

  Patient problems: Injury; No Information

  MAUDE report 6974791 ↗
• InjuryJun 21, 2017Positioning Problem; Positioning Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION THR WITH EXCHANGE OF POLY LINER & FEMORAL HEAD DUE TO ECCENTRIC HEAD POSITION, POLY WEAR AND LARGE EFFUSION AROUND HIP JOINT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6656441 ↗