MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-056
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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 or Problem Description
It was reported that on (b)(6) 2019 the patient underwent a revision surgery due to the ¿prosthesis fracture¿ of the pinnacle implant, and subsequent ¿replacement of the stem and of the polyethylene liner¿.The above impacted implant was implanted on (b)(6) 2010 after a revision and replacement of the asr implant that the patient received on (b)(6) 2008.Litigation alleges prosthetic fracture.Plaintiff is seeking full compensation for all the damages that had caused her such as permanent biological injury, impaired mobility, limited adl, joint insufficiency, financial losses and social interactions due to defective and lack of safety products implanted.Doi: (b)(6) 2008; dor: (b)(6) 2019: right hip 2nd revision (stem).Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip 2nd revision (cup, liner and head).

• Brand Name: PINNACLE MULTIHOLE II CUP 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11223406
• Report Number: 1818910-2021-01733
• Device Sequence Number: 19772158
• Product Code: LPH
• UDI-Device Identifier: 10603295009641
• UDI-Public: 10603295009641
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1217-20-056
• Device Catalogue Number: 121720056
• Device Lot Number: EB2G91000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +8.5; CORAIL2 NON COL HO SIZE 13; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 10D 36IDX56OD; PINNACLE BONE SCREW 35 MM; PINNACLE MULTIHOLE II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR