MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-058
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
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 abnormal radiographic evaluation - polywear.Event is not serious and is considered mild.Event is definitely related to both device and procedure.Date of implant: (b)(6) 2013.Date of event: (b)(6) 2019.(left hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: b5.
Event or Problem Description
Additional information received for medical records and it was noted that on (b)(6)2013: patient underwent a left hip replacement.No complications noted.(b)(6) 2019: office note indicated the patient is satisfied with his left hip replacement.Images indicated all components are in good position with no loosening.Mild poly wear was noted of 2mm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: investigative update: 13 / december / 2021 x-ray images have been provided for review.No device associated with this report was received for examination.Two provided x-ray images have been reviewed.The x-ray images show what appear to be well placed implants.No obvious material wear or anything indicative of a product problem identified.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN MAR NEUT 36IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9329901
• Report Number: 1818910-2019-116507
• Device Sequence Number: 16798294
• Product Code: LPH
• UDI-Device Identifier: 10603295014478
• UDI-Public: 10603295014478
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1219-36-058
• Device Catalogue Number: 121936058
• Device Lot Number: E41HN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/05/2019; 01/07/2020; 01/10/2022
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/06/2019; 01/16/2020; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 36MM +1.5; PINNACLE SECTOR II CUP 58MM; SUMMIT POR TAPER SZ6 STD OFF
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White