MAUDE Adverse Event Report: BIOMEDTRIX, LLC UNIVERSAL HIP SYSTEM ; CANINE TOTAL HIP REPLACEMENT (THR)

Catalog Number 10-203-34-17

Device Problems Nonstandard Device (1420); Difficult To Position (1467); Device Markings/Labelling Problem (2911)

Patient Problems Feeding Problem (1850); Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Dislocation (2374); Impaired Healing (2378); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 04/15/2015

Event Type  Injury  

Event Description

My dog received a hip replacement during (b)(6) 2015, manufactured for biomedtrix llc., company ((b)(4)) and during the first procedure, the doctor (dr.(b)(6)) discovered he had received a "mix product" (misbranded and adulterated medical device) and he had to close the wound (had already cut bones).The next day, the dr had to re-open the wound and finish the (2nd) surgery.The first surgery for the hip replacement was performed with a screw attachment system.After 6 weeks, the dog dislocated the hip which the doctor indicated was not common and then had to go back and perform another (3rd) surgery with another type of hip cup which had to be cemented to the hip.After several days, the dog had a chronic allergic reaction and had to be hospitalized for recuperation.After 6 months, the dog has not recuperated.The dog is limping, in-pain, can't sit down, does not eat normally due to the pain and takes medication for the pain.I had contacted the mfr during the past 8 months without obtaining any reasonable response regarding my complaint.I had reviewed the fda site and per their definition the agency had regulatory oversight of a misbranded and adulterated medical device used for humans and/or animals, which applies due to nonconforming product was due to mixed product.The hip replacement system box indicates that the product is manufactured for biomedtrix.However, the product is supposedly manufactured in (b)(4), which is not indicated on the package and no ce mark is indicated.The mfr (biomedtrix, llc.) indicated that they had to initiate a national recall regarding the "mix product" (misbranded and adulterated medical device) lot incident.Biomedtrix, llc, never communicated the assignment of a mfr compliant number to me.(b)(4) biomedtrix, llc., had indicated to me by phone communication that products had to be recalled within the united states and had indicated that another incident had been reported from (b)(6).(b)(4) biomedtrix, llc., had indicated to me by phone communication that they were not regulated by fda and/or any (b)(6) governmental agency.

• Brand Name: UNIVERSAL HIP SYSTEM
• Type of Device: CANINE TOTAL HIP REPLACEMENT (THR)
• Manufacturer (Section D): BIOMEDTRIX, LLC; 50 intervale rd; boonton NJ 0700
• MDR Report Key: 5347372
• MDR Text Key: 35276472
• Report Number: MW5058903
• Device Sequence Number: 1
• Product Code: LPH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 10-203-34-17
• Device Lot Number: 762713
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Weight: 54