PRODIGY 1520-21-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295056874), received between Aug 17, 2017 and Mar 3, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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.

• InjuryMar 3, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT HIP AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. REPLACEMENT OF PINNACLE 50 X 28 METAL LINER AND 28MM 1.5 FEMORAL HEAD. ACETABULAR LINER WAS REPLACED WITH A PINNACLE DUAL MOBILITY 50 X 43 LINER AND A COMPETITOR FEMORAL STEM DURING REVISION SURGERY. DOI: 2004. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11404216 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS COMPLAINING OF HIP PAIN, THEN THE PATIENT FOR ADVERSE LOCAL TISSUE REACTION OF RIGHT METAL-ON-METAL TOTAL HIP ARTHROPLASTY. OPERATIVE FINDINGS REPORTED THAT THERE IS A LARGE AMOUNT OF STRAW-COLORED FLUID OF APPROXIMATELY 8 ML THAT WAS ASPIRATED. ON ENTRY INTO THE DEEP FASCIA, THERE WAS OVERALL LARGE PSEUDOTUMOR FORMATION. THERE IS A LARGE AMOUNT OF FATTY INFILTRATE ALONG HER POSTERIOR CAPSULE INSERTIONS. THERE IS LOSS OF ABDUCTORS OF AT LEAST 25% OF THE GLUTEUS MINIMUS. THERE IS A LARGE CYSTIC FORMATION ANTERIOR AND ANTEROLATERAL ALONG HER PROXIMAL FEMUR. THERE IS NECROTIC DEBRIS IN THE CYSTIC FORMATION. WHEN THE FEMORAL HEAD WAS REMOVED, THERE IS A SMALL RING OF BLACK PRECIPITATE ON THE COBALT CHROME HEAD. IT SHOULD BE NOTED THAT THE STEM IS ALSO COBALT. SO, AGAIN SIGNIFICANT LOSS OF SOFT TISSUE STRUCTURES WITH FATTY INFILTRATE ALONG POSTERIOR NECROSIS AND FATTY INFILTRATE ALONG THE ABDUCTORS AND A LARGE CYSTIC FORMATION ANTERIORLY WITH LOSS OF ABDUCTORS, QUADRICEPS, AND ANTERIOR STRUCTURES. DOI: (B)(6) 2007; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 9720632 ↗
• InjuryDec 17, 2018Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2010; (RIGHT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8170337 ↗
• InjuryFeb 12, 2018Degraded; Appropriate Device Problem Term/Code Not Available; Degraded; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES PATIENT HAD PAIN AND THE ABILITY TO PERFORM NORMAL ACTIVITIES HAS BEEN IMPAIRED AFTER ASR HIP IMPLANT. DOI: (B)(6) 2006 (LEFT HIP). DOR: (B)(6) 2017. PATIENT IS RESIDENT OF (B)(6). UPDATE 08/28/2012 LITIGATION PAPERS RECEIVED. THEY ARE THE SAME PAPERS USED TO CREATE THIS COMPLAINT FILE. UPDATE 2/1/2013 - ASR/SUPPLEMENTAL INFORMATION RECEIVED. PART/LOT INFORMATION WAS UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

  Patient problems: Bone Fracture(s); Distress; Foreign Body Reaction; Injury; Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 7263444 ↗
• InjuryAug 17, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION ALLEGES THAT AFTER THE SURGICAL IMPLANTATION OF THE ASR HIP IMPLANT DEVICE, PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO PAIN AND DISCOMFORT; THE FORMATION OF METALLOSIS AND PSEUDOTUMORS WHICH HAVE DAMAGED BONE AND TISSUE SURROUNDING THE IMPLANT; STIFFNESS; INFLAMMATION; CHROMIUM AND COBALT METAL TOXICITY; LACK OF MOBILITY; AND OTHER COMPLICATIONS. **UPDATE** 10/03/2013- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED SIDE, DOB, AND PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE JUL 18, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, REVISION NOTES REPORTED FLUID IN THE HIP JOINT AND METAL WEAR DEBRIS ON THE TRUNNION. THERE WAS NO MENTION OF METALLOSIS OR PSEUDOTUMORS. NO LABORATORY VALUES PROVIDED FOR THE ALLEGED CHROMIUM-COBALT TOXICITY. STEM AND SLEEVE WERE ADDED DUE TO THE REPORTED METAL WEAR AND CHROMIUM-COBALT TOXICITY. PRO

  Patient problems: Discomfort; Foreign Body Reaction; Host-Tissue Reaction; Inflammation; Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain

  MAUDE report 6800160 ↗