MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 64MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-30-064

Device Problems Use of Device Problem (1670); Osseointegration Problem (3003); Migration (4003)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hematoma (1884); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation record received.Litigation alleges that the patient was diagnosed with fibroadipose tissue and focal synovium with chronic inflammation, hemosiderosis and metallosis.Doi: (b)(6) 2017, dor: (b)(6) 2017, right hip (second revision).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN MULTIHOLE W/GRIPTION 64MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14336360
• MDR Text Key: 291203457
• Report Number: 1818910-2022-08436
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010043
• UDI-Public: 10603295010043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 1217-30-064
• Device Catalogue Number: 121730064
• Device Lot Number: C17646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 40IDX64OD; DELTA CER HEAD 11/13 28MM +6; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX8MM; PINN MULTIHOLE W/GRIPTION 64MM; SELF CENT HIP 40X28 RUST; SROM*STM ST,36+8L NK,18X13X160
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female