MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CERAMAX CERAMIC INSERT 36 X 54; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number	121887654
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Irritation (2076)
Date of Event	10/09/2019
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
Subject id: (b)(6).Study: (b)(6).Clinical adverse event received for iliopsoas bursitis of left (study) hip event is not serious and is considered moderate event is not related to device and is related to procedure.Date of implantation: (b)(6) 2017.Date of event (onset): (b)(6) 2019 (left hip).Treatment: injection into iliopsoas bursa.Product details: component: summit stem porocoat std offset sz 6, catalog number: 157001120, lot number id: h33727.Component: ceramax ceramic insert neutral 54mm od 36mm id, catalog number: 121887654, lot number id: 849743.Component: pinnacle shell sector 54mm, catalog number: 121722054, lot number id: hc0470.Component: biolox delta femoral head ceramic 36mm +8.5, catalog number: 136536330, lot number id: 8550546.Component: cancellous bone screw 35mm, catalog number: 121735500, lot number id: d16091490.
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).Investigation summary : 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.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: CERAMAX CERAMIC INSERT 36 X 54
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9451203
• Report Number: 1818910-2019-122317
• Device Sequence Number: 16602751
• Product Code: MRA
• UDI-Device Identifier: 10603295012528
• UDI-Public: 10603295012528
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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 Catalogue Number: 121887654
• Device Lot Number: 8498743
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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: 40 YR
• Patient Weight: 91