MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ALTRX +4 10D 36IDX66OD; HIP ACETABULAR INSERT/LINER

Catalog Number	122136166
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Surgeon did the first left hip revision removing a howmedica pca stem and cup on (b)(6) 2017.Due to the bone loss and poor quality she decided to utilize the lps proximal femur and 66mm multihole pinnacle cup.The patient did well until recently, today he had a second dislocation which could not be reduced in the er.When the surgeon entered the joint she found a large piece of scar tissue in the acetabulum.Surgeon removed it as well as other tissue that could impinge.The 36mm head and liner were removed and a 40mm head and liner were used to increase stability.
Additional Manufacturer Narrative
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 will be filed as appropriate.

• Brand Name: ALTRX +4 10D 36IDX66OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6675029
• Report Number: 1818910-2017-20291
• Device Sequence Number: 46057
• Product Code: LPH
• UDI-Device Identifier: 10603295016472
• UDI-Public: 10603295016472
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: 122136166
• Device Lot Number: 574526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/27/2017
• 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 Weight: 113