MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-456
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/01/2006
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
Clinical adverse event received for deep infection.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2001, date of event (onset): (b)(6) 2006, (left hip).Treatment: hip was eventually explanted & revised in (b)(6) 2011, in another state/another hospital.
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: it is reasonable there was no error in the sterile processing, manufacturing or material of this product/lot combination that would be a contributing factor in the reported allegations.A manufacturing records evaluation (mre) was not performed.Corrected h6 health effect - clinical code: appropriate term / code not available (e2402) from the initial medwatch used to capture patient harm infection (e19).

• Brand Name: PINN MAR +4 NEUT 32IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11333206
• Report Number: 1818910-2021-03074
• Device Sequence Number: 14098596
• Product Code: LPH
• UDI-Device Identifier: 10603295014355
• UDI-Public: 10603295014355
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2011
• 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): 02/01/2021

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: 1219-32-456
• Device Catalogue Number: 121932456
• Device Lot Number: U5HM21001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: P.F.C.* 32MM HEAD +0MM; PFC* CEMENTED FEM STEM, SZ 3M; PINN MAR +4 NEUT 32IDX56OD; PINNACLE SECTOR ACET CUP 56MM; UNKNOWN BONE CEMENT; P.F.C.* 32MM HEAD +0MM; PFC* CEMENTED FEM STEM, SZ 3M; PINN MAR +4 NEUT 32IDX56OD; PINNACLE SECTOR ACET CUP 56MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 107