MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/23/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Study: (b)(6).Clinical adverse event received for intraoperative bone fracture.Event is serious.Event is possibly related to device and is probably related to procedure.Date of implantation: (b)(6) 2010, date of event (onset): (b)(6) 2010, (right hip).Treatment: intraoperative orif.Additional information received: on (b)(6) 2010, the patient underwent a primary right hip arthroplasty due to avascular necrosis.During impaction of the acetabular cup, a small fracture was noticed in the posterior wall.The acetabular fracture was corrected intra-operatively with a 5-hole small fragment pelvic reconstruction plate along with four screws.
Additional 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: a search of the non-conformance (nc) system finds no ncs associated with this product/lot combination.Device history review: a search of the non-conformance (nc) system finds no ncs associated with this product/lot combination.

• Brand Name: PINNACLE 100 ACET CUP 58MM
• 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: 11372429
• Report Number: 1818910-2021-03731
• Device Sequence Number: 934695
• Product Code: LPH
• UDI-Device Identifier: 10603295008583
• UDI-Public: 10603295008583
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 1217-01-058
• Device Catalogue Number: 121701058
• Device Lot Number: EG7HG1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: 11/13 S-ROM 40MM M SPEC+6; ALTRX +4 10D 40IDX58OD; APEX HOLE ELIM POSITIVE STOP; S-ROM*SLEEVE PRX ZTT, 22F-XXL; SROM STM STD 36+12L 17X22
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 162