PINNACLE Hip Solutions 1218-64-053Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295520337), received between May 24, 2021 and Nov 10, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO A SX FOR A DISLOCATED HIP, DEVELOPED AN INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 23510855 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED HIP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21691190 ↗
• InjuryDec 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED POST REVISION THA. PATIENT HAS A FUSED SPINE AND HAS SIGNIFICANT BACK PAIN. COMPONENTS ARE FOUND TO BE WELL POSITIONED HOWEVER DUE TO PATIENT REQUEST AND HIS LACK OF COMPLIANCE WITH POST OPERATIVE MOVEMENTS DUE TO HIS BACK PAIN, WAS CONVERTED TO A CONSTRAINED LINER. THERE WAS NO DELAY NOT PATIENT HARM. METAL DM LINER WAS PLACED ON (B)(6) 2024. POLY DM LINER AND HEAD WERE PLACED ON (B)(6) 2024 DUE TO POSTOPERATIVE DRAINAGE AND SURGEON CHOSE TO EXCHANGE THESE DUE TO INFECTION RISK. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 20891411 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DISLOCATED POST REVISION THA. PATIENT HAS A FUSED SPINE AND HAS SIGNIFICANT BACK PAIN. COMPONENTS ARE FOUND TO BE WELL POSITIONED HOWEVER DUE TO PATIENT REQUEST AND HIS LACK OF COMPLIANCE WITH POST OPERATIVE MOVEMENTS DUE TO HIS BACK PAIN, WAS CONVERTED TO A CONSTRAINED LINER. THERE WAS NO DELAY NOT PATIENT HARM. METAL DM LINER WAS PLACED ON (B)(6) 2024. POLY DM LINER AND HEAD WERE PLACED ON (B)(6) 2024 DUE TO POSTOPERATIVE DRAINAGE AND SURGEON CHOSE TO EXCHANGE THESE DUE TO INFECTION RISK. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20854648 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE REASON THERE WERE 2 LINERS USED IN THIS CASE WAS DUAL MOBILITY. WE USE A PINNACLE DM LINER AND THEN A BIMENTUM LINER. SERF WILL RECEIVE NOTHING AS THE HOSPITAL PUTS THESE ON LEGAL HOLD. THE FEMORAL STEM WAS A BIOMET STEM.

  Patient problems: Unspecified Infection

  MAUDE report 20524458 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TO BE REVISED DUE TO PAIN AND IMPINGING ON THE CUP. HE HAD NOT DISLOCATED YET BUT WAS PAINFUL. CUP WAS VERTICAL AND THE STEM WAS UNDERSIZED. CUP AND STEM WERE REMOVED AND REPLACED WITH LARGER SIZE IMPLANTS. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20268908 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REVISED THE PATIENT'S ACETABULAR COMPONENT AND ADJUSTED THE CUP POSITION FOR IMPROVED STABILITY FOLLOWING DISLOCATION. THE PATIENT RECEIVED A NEW LINER AND HEAD BALL AFTER THE CUP POSITION WAS ADJUSTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17622538 ↗
• InjuryMay 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS WOUND BREAKDOWN WITH HEMATOMA AND DRAINAGE, RECURRENT INSTABILITY WITH DISLOCATION, AND COAGULOPATHY. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A REVISION 6 WEEKS PRIOR (CAPTURED IN (B)(4)) TO ADDRESS A FAILED CONSTRAINED LINER AND MEDICAL RECORDS INDICATED THE PATIENT WAS HAVING PAIN.. THE PATIENT DISLOCATED AFTER THAT SURGERY AND NEEDED A REDUCTION. DURING THIS CURRENT PROCEDURE THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE SURGEON REPORTED FINDING A COMPLETE FAILURE OF THE POSTERIOR SOFT TISSUE, AND REALLY NO LONGER ANY SOFT TISSUES PRESENT TO REPAIR. THERE WAS A SMALL AMOUNT OF HEMATOMA. HE WAS COAGULOPATHIC DURING THE CASE.

  Patient problems: Fluid Discharge; Hematoma; Joint Dislocation; Joint Laxity; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11871927 ↗