MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. / JOHNSON & JOHNSON MEDICAL INC. DEPUY PINNACLE ACETABULAR SYSTEM; PROSTHESIS, HIP, SEMI - CONSTRAINED, METAL / POLYMER POROUS UNCEMENTED

Model Number REF 1217-32-052

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/07/2012

Event Type  Injury  

Event Description

My name is (b)(6), i am a totally and permanently disabled veteran.(b)(6) 2012, i had my right hip replaced with depuy pinnacle acetabular lot #259100, serial # (b)(4), model number same as serial number, size 52 mm/ right hip, by (b)(6) hospital.On (b)(6) 2012, i was walking in my driveway my foot slipped off the edge, i felt a pop and dislocated my hip.Ems and the fire department took me to (b)(6) hospital in (b)(6).They did the procedure to correct it in the operating room.The next morning (b)(6) 2012, it happened again when i was getting out of bed.(b)(6) 2013 another dislocation occurred.Between (b)(6) 2013 and my revision surgery (b)(6) 2016 five more happened one while i was standing and urinating in the bathroom, and two in my bedroom standing talking to my wife, all documented in my veterans medical records.When the orthopedic surgeon did my revision surgery, he found the cup was broke.I kept complaining about the pain since the first dislocation.I know that i can't be the only one this has happened to.I ask you please, please investigate, there are a great amount of patients like me having problems with this specific device.I thank you very much for your time.(b)(6).

Event Description

Add'l info received from reporter on 05/13/2019 for report mw5082722.I reported a faulty device late last year, a prosthetic hip (a broken cup).One of the drs said it was a cup.I looked through my records finding, it was the liner that had broken.Item: depuy pinnacle acetabular shell sector model number refer: 1217-32-052, lot # 259100, sn# (b)(4), size: 52mm od/right hip; item: depuy femoral stem model number refer: 1570-02-100, lot #258057, sn #(b)(4), size 4 x 140mm / right hip; item: depuy femoral head model number refer: 1365-52-000, lot # 3480039, sn # (b)(4), size: 36mm / right; item depuy pinnacle acetabular liner model number refer: 1221-36-152, lot # 249003, serial number ref: (b)(4), size 36mm x 52mm od right hip.Depuy sent me a letter dated april 5, 2019 stating that it was an unk hip acetabular liner and unk hip femoral head.I have official records at the (b)(6) medical center in (b)(6) and in my procession that states otherwise.I can be reached at (b)(6).I am totally and permanently disabled and accessible at any time of the day.I thank you very much.(b)(6).Fda safety report id# (b)(4).

• Brand Name: DEPUY PINNACLE ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI - CONSTRAINED, METAL / POLYMER POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. / JOHNSON & JOHNSON MEDICAL INC.
• MDR Report Key: 8208458
• MDR Text Key: 132104006
• Report Number: MW5082722
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 12/27/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REF 1217-32-052
• Device Lot Number: 259100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 114