inforMED
InjuryMBV

AGC ANATOMIC POR FMRL 60 RIGHT

Received Aug 4, 2020 · Event occurred Jul 16, 2020

Report 0001825034-2020-03008 · MDR key 10364805

Device

Generic name

Prosthesis, Knee

Model number

N/A

Catalog number

152732

Lot number

437760

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Extraskeletal ossification
  • Muscular Rigidity
  • Pain
  • Limited Mobility Of The Implanted Joint
  • Extraskeletal ossification
  • Muscular Rigidity
  • Pain
  • Limited Mobility Of The Implanted Joint

Narrative

Additional Manufacturer Narrative

(B)(4). MEDICAL PRODUCT: CATALOG # LOT #. BIOMET CC CRUCIATE TRAY 67MM CATALOG # 141232 LOT # 582040. GEN 4 CEMVACPAC 80 GRSINGLE PK CATALOG # 402401 LOT # 069440. UNIVERSAL Z/HALL STYL 19.7X100 CATALOG # 516065 LOT # 88685. BIOMET ARCOM PAT ALL POLY 25MM CATALOG # CP102790 LOT # 269420. AGC TRAD PRI TIB BEAR 12X63/67 CATALOG # 151006 LOT # 390650. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2020-02782. 0001822565-2020-02818. HETEROTOPIC OSSIFICATION IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, CAUSING PAIN AND IRRITATION TO THE SURROUNDING TISSUES. THE ONLY TREATMENT IS SURGICAL EXCISION OR SHAVING DOWN TO SMOOTH OUT THE EXCESS BONE. AS TIME FRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED.  PLEASE CONSIDER COMPLAINT CATEGORY MEDICAL: HETEROTOPIC OSSIFICATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO HETEROTROPIC BONE OSSIFICATION, WHICH CONTRIBUTED TO THE PATIENT EXPERIENCING LIMITED RANGE OF MOTION, PAIN, AND STIFFNESS. THE SURGEON REMOVED EXCESS BONE AND REPLACED THE ARTICULAR SURFACE PROSTHESIS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.