S-ROM 1365-18-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295033165), received between Jan 3, 2013 and May 25, 2021 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IN PAIN, PSEUDO TUMOR, REVISION OF RIGHT HIP. METAL ON METAL DEVICE. PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 11880266 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS REVISION I AND D FOR INFECTION. PATIENT HAS OUR STEM AND A COMPETITIVE COMPANIES CUP. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11237743 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS ADMITTED DUE TO PAIN AND WAS FOUND TO HAD DEVELOPED POST-OP INFECTION. IRRIGATION AND DEBRIDEMENT PLUS IV ANTIBIOTIC TREATMENT DONE ON (B)(6) 2008. SUBSEQUENTLY, REVISION WAS MADE ON (B)(6) 2008. REVISION NOTES REPORTED PURULENCE BETWEEN THE LINER AND SHELL. THE ACETABULUM WAS ALSO FOUND TO BE LOOSE WITHOUT OSTEAL INTEGRATION. THE RIGHT HIP AREA WAS SWOLLEN AND REDDENED. RE-REVISION DONE ON (B)(6) 2009 TO REMOVE THE NON-ARTICULATING ANTIBIOTIC SPACER AND IMPLANTATION OF DEFINITIVE IMPLANTS; NON-DEPUY DEVICES WERE USED. MOREOVER, DURING THE INITIAL HIP REPLACEMENT ON (B)(6) 2007, THE SROM STEM AND SLEEVE WERE TOO TIGHT IN THE BONE SO THE SROM STEM BACKED OUT AND FEMUR OVER REAMED TO 12MM. A CABLE WAS USED TO AVOID INSERTIONAL FRACTURE. IN THIS COURSE, IT RESULTED TO POSTERIOR AVULSION OF THE GREATER TROCHANTER. LATER ON (B)(6) 2007, AN I&D AND EVACUATION OF HEMATOMA WAS DONE AND THE AVULSION WAS REPAIRED. DOI: (B)(6) 2007 (CUP, LINER, SLEEVE, SCREWS); DOI: (B)(6) 2008 (HEAD, STEM). DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9700091 ↗
• InjuryFeb 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT PATIENT HAD A FALL ON 31 MAR 2018 AND HAD DISLOCATION. CLOSE REDUCTION WAS NOT SUCCESSFUL. THE PATIENT WAS THEN REVISED WITH DIAGNOSIS OF DISLOCATION OF THE LEFT HIP REPLACEMENT, HISTORY OF ACUTE PERIPROSTHETIC INFECTION OF THE LEFT HIP REPLACEMENT AND FRACTURE OF THE GREATER TROCHANTERIC FRAGMENT, LEFT HIP. OPERATIVE NOTES INDICATED THAT AFTER DISSECTING THROUGH THE SUBCUTANEOUS LAYER, WE NOTICED IMMEDIATELY A LARGE SEROMA-HEMATOMA. THERE WAS PARTIAL DEHISCENCE OF THE FASCIAL CLOSURE. MIGRATION OF THE TROCHANTERIC FRAGMENT THAT WAS PREVIOUSLY REPAIRED USING NON-ABSORBABLE SUTURES. LINER IS A COMPETITOR. DOI: (B)(6) 2005 (STEM); DOI: (B)(6) 2018 (HEAD); DOR: (B)(6) 2018 (HEAD); LEFT HIP. 1ST REVISION WAS CAPTURED ON (B)(4).

  Patient problems: Hematoma; Joint Dislocation; No Code Available; Seroma; Wound Dehiscence

  MAUDE report 9661433 ↗
• InjuryOct 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AFTER BEING KICKED BY THE HORSE. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9219755 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE SURGEON REMOVED THE BIPOLAR CUP AND REPLACED IT WITH A PINNACLE GRIPTION CUP. THE HEAD WAS REPLACED AS WELL. DOI: 2014, DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 8940199 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS LEFT PERIPROSTHETIC FEMORAL SHAFT FRACTURE. BEFORE THE REVISION, THE PATIENT REPORTED INJURY, SEVERE PAIN, LOSS OF CONSCIOUSNESS, SEIZURE, WEAKNESS, DIZZINESS, LOSS OF VISION, HEARING LOSS OR CHEST PAIN,ABDOMINAL PAIN, FEVER, AND VOMITING, TROUBLE WALKING, LIMITED ROM,SWELLING, SHORTENING OF LEFT HIP. REVISION NOTES REPORTED OF FEMORAL STEM REVEALED THAT THE SLEEVE WAS BONY INGROWN. A TAMP WAS USED TO LOOSEN THE METAL LINER AND THEN THIS WAS REMOVED. THE FRACTURE ITSELF WAS EXPOSED THROUGH THE VASTUS LATERALIS. FRACTURE WAS BYPASSED. THERE WAS A SMALL BUTTERFLY FRAGMENT MEDIALLY. OPERATIVE NOTES STATED THAT A FRACTURE OF THE MID FEMORAL DIAPHYSIS WAS NOTED. DOI: (B)(6) 2005-DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: Abdominal Pain; Chest Pain; Dizziness; Fever; Hearing Impairment; Injury; Loss of Range of Motion; No Code Available; Pain; Seizures; Swelling; Vomiting; Weakness

  MAUDE report 8717390 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM HEAD AND LINER EXCHANGE.

  Patient problems: No Code Available; Test Result

  MAUDE report 8201000 ↗
• InjuryJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PINNACLE PPF AND STICKER SHEET RECORDS RECEIVED. PPF ALLEGES ELEVATED METAL IONS CONFIRMED IN MEDICAL RECORDS. ALL DEPUY IMPLANTS WERE REMOVED AND REPLACED TO A COMPETITOR HIP. DOI: (B)(6) 2006; DOR: (B)(6) 2013; LEFT HIP.

  Patient problems: Test Result

  MAUDE report 7646452 ↗
• InjuryJan 3, 2013Material Disintegration; Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND HIGH SERUM CHROMIUM LEVELS.

  Patient problems: Discomfort; Host-Tissue Reaction; Inflammation; Injury; Joint Dislocation; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Swelling; Swelling/ Edema; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 2894064 ↗