MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M 28MM 5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-12-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
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
The primary surgery was performed via tha (the date was unknown).It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the head (p/n: (b)(4)), the liner (p/n: (b)(4)) and the cup (kyocera¿s product, p/n: (b)(4)) due to acetabular osteolysis caused by mom.The surgery was completed, and it was unknown whether there was a surgical delay.The customer requests the investigation for the wear conditions of the connection of the cup and the liner, the liner¿s sliding surface, and neck-head junction.No further information is available.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report 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.
Additional Manufacturer 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.H10 additional narrative: corrected: retracting d10 and h3 from the previously submitted medwatch.Physical product has not been returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary update 28-jul-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ARTICULEZE M 28MM 5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10012599
• Report Number: 1818910-2020-11539
• Device Sequence Number: 2089724
• Product Code: JDI
• UDI-Device Identifier: 10603295033097
• UDI-Public: 10603295033097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1365-12-500
• Device Catalogue Number: 136512500
• Device Lot Number: 3211697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/14/2020; 05/19/2020; 06/12/2020; 08/18/2020; 11/25/2020; 07/29/2021
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/18/2020; 05/21/2020; 06/12/2020; 08/19/2020; 12/17/2020; 07/30/2021
• 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: ARTICULEZE M 28MM 5; PINNACLE BANTAM ACET CUP 46MM; PINNACLE MTL INS NEUT28IDX46OD; ARTICULEZE M 28MM 5; PINNACLE MTL INS NEUT28IDX46OD
• Outcome Attributed to Adverse Event: Required Intervention