MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 36IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122136160
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
After the first revision, ppf alleges pulmonary embolism.(right hip).
Additional Manufacturer Narrative
This is a duplicate report of 1818910-2019-91112.1818910-2019-90946 is being retracted as it is a report duplication.1818910-2019-91112 will be kept for investigation purposes.Product complaint # (b)(4).

• Brand Name: ALTRX +4 10D 36IDX60OD
• 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: 8524593
• Report Number: 1818910-2019-90946
• Device Sequence Number: 2798219
• Product Code: KWA
• UDI-Device Identifier: 10603295016441
• UDI-Public: 10603295016441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 122136160
• Device Lot Number: 346275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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