MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 41X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103541000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Death
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.(b)(4).Attorney.
Event or Problem Description
It is reported that the patient was revised to address a right extra capsular neck of femur fracture and pain.
Additional Manufacturer Narrative
Product complaint #: (b)(4).From serious injury to death as the patient had passed away 5 months after surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: a review of complaints databases and manufacturing records did not identify any anomalies 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 review of lot hj0986 did not identify any anomalies or deviations.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.

• Brand Name: SELF CENT HIP 41X28 RUST
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8179397
• Report Number: 1818910-2018-78698
• Device Sequence Number: 13849992
• Product Code: KWY
• UDI-Device Identifier: 10603295003311
• UDI-Public: 10603295003311
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2018

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 103541000
• Device Lot Number: HJ0986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2018
• Supplement Date Received by Manufacturer: 11/25/2018; 02/22/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 12/19/2018; 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention