MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR MAR 10D LNR 32IDX54OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1220-32-154
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); No Code Available (3191)
Date of Event	02/26/2019
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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional: "attorney".(b)(4).
Event or Problem Description
Patient's lawyer sent a letter to j&j medical as he is claiming compensation: patient received hip-tep right side on (b)(6) 2015.On (b)(6) 2018 pe wear was diagnosed in hospital and a doctor`s report stated "the amount of wear within this short period is very unusual.Material defect (in gamma sterilisation) possible.Change of inlay in time interval necessary." dor: (b)(6) 2019.
Additional Manufacturer Narrative
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.Product complaint # (b)(4).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.Corrective action was not indicated.Device history lot : 8085898.Device history batch : null.Device history review : a review of the poly liner, lot 8085898 manufacturing records identified no non-conformances, anomalies or deviations and confirmed that 30 off products were finish manufactured 27-march-2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
After review of medical records the patient was revised to address pe abrasion of tep right hip, hyperuricemia, reduction in height of the pe inlay due to abrasion.Operative note reported scarcely toxic granulation carrying pseudo capsule.
Additional Manufacturer Narrative
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.H6 patient code: no code available (3191) used to capture the limb asymmetry.
Additional Manufacturer Narrative
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.  h10 additional 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.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.Corrective action was not indicated.Device history lot: 8085898.Device history batch: null.Device history review: a review of the poly liner, lot 8085898 manufacturing records identified no non-conformances, anomalies or deviations and confirmed that 30 off products were finish manufactured 27-march-2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DUR MAR 10D LNR 32IDX54OD
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8619519
• Report Number: 1818910-2019-93812
• Device Sequence Number: 2117785
• Product Code: LPH
• UDI-Device Identifier: 10603295015543
• UDI-Public: 10603295015543
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K994415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 1220-32-154
• Device Catalogue Number: 122032154
• Device Lot Number: 8085898
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019; 01/22/2020; 03/31/2020
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/26/2019; 01/31/2020; 04/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR