MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928150
Medical Device Problem Codes	Naturally Worn (2988); Separation Problem (4043)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Not Applicable (3189)
Date of Event	08/17/2018
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
Customer reported to (b)(6): "primary implantation of a cementless depuy hip-tep (pinnacle cup / corail stem) right on (b)(6) 2015.Initially inconspicuous post-op course.Patient indicated occurrence of noise phenomena in the area of the hip tep on the right side since about (b)(6) 2016.A previous relevant trauma / movement moment is negated by the patient.In the further course persistence of noice phenomena and additionally pain since (b)(6) 2018.Thereupon visit at the orthopedic practitioner on (b)(6) 2018 and x-ray examination of right hip-tep.On the same day visit at our hospital´s orthopedic emergency room.Radiograph showed decentralisation of hip head of the hip prosthesis without evidence of luxation.On (b)(6) 2018 revision of hip-tep right side.Intraoperatively a severe metallosis and a dislocation of the inlay from the pinnacle-pressfit cup was obvious - an explanatory correlate for this was not evident.In addition there was wear/damage of pinnacle cup caused by the ceramic head.A radical debridement was done as well as a revision of hip-head and cup.".
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device was returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: the devices were reviewed by bioengineering; root cause undetermined depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device lot 429263 and no non-conformances were identified 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.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.

• Brand Name: PINN MAR +4 10D 28IDX50OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7881537
• Report Number: 1818910-2018-69527
• Device Sequence Number: 1939622
• Product Code: LPH
• UDI-Device Identifier: 10603295013464
• UDI-Public: 10603295013464
• Combination Product (Y/N): N
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 121928150
• Device Lot Number: 429263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 02/06/2019; 04/29/2019
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/08/2018; 02/15/2019; 05/09/2019
• 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 Age: 76 YR