MAUDE Adverse Event Report: DEPUY/ JOHNSON JOHNSON / JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. DEPUY PINNACLE CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 12/03/2021

Event Type  Injury  

Event Description

Depuy pinnacle cup failed causing metallosis.Test results were 5 times over the minimum allowable range.Fda safety report id# (b)(4).

• Brand Name: DEPUY PINNACLE CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): DEPUY/ JOHNSON JOHNSON / JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
• MDR Report Key: 13543644
• MDR Text Key: 285760397
• Report Number: MW5107498
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2022

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Patient Sequence Number: 1
• Treatment: B10; FISH OIL; GLUCOSAMINE; MULTIVITAMIN; PROBIOTICS; Q10; TURMERIC
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White