MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PINN LNR CON +4 10D 32IDX58OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-32-758
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Naturally Worn (2988)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
(b)(6).Associated study: dots.Clinical adverse event notification received for abnormal radiographic evaluation- polywear.Event is not serious and is considered mild in severity.Event is related to both device and procedure.Doe: (b)(6) 2018; doi: (b)(6) 2012; (left hip).Following xrays.
Additional Manufacturer Narrative
(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.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.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).H6 patient code: no code available (3191) used to capture the surgical intervention, medical device removal and no information available.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. .
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.This is to correct the date received by manufacturer submitted on mwr (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : update 28-sep-2021.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 LNR CON +4 10D 32IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46582 0988
• MDR Report Key: 7822913
• Report Number: 1818910-2018-67929
• Device Sequence Number: 11086075
• Product Code: KWZ
• UDI-Device Identifier: 10603295012023
• UDI-Public: 10603295012023
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/07/2018

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: 1218-32-758
• Device Catalogue Number: 121832758
• Device Lot Number: D59JV1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 01/07/2019; 01/07/2020; 09/28/2021
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/02/2018; 01/30/2020; 02/04/2020; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 109