MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 44IDX64OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122144164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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.Concomitant medical products: asphere m spec 11/13 44 +6 head; altrx +4 10d 44idx64od liner; pinn dp revsn w/gription 70mm cup; pinn can bone screw 6.5mmx20mm; pinn can bone screw 6.5mmx40mm x 2; unknown hip femoral stem.Initial reporter occupation: non-healthcare professional.
Event or Problem Description
Ppf and sticker sheets received.There is no allegation.It was indicated that patient had a second revision on (b)(6) 2014.The cup, head and liner were removed.Doi: (b)(6) 2011- dor: (b)(6) 2014; (left hip).
Additional Manufacturer Narrative
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 will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
After review of medical records, patient was revised to address pain.Revision notes stated that there was going to fractured off when removing the stem itself.The part of trochanter was thin at this point anteriorly that there was just almost no connection between the diaphysis and the trochanter itself.

• Brand Name: ALTRX +4 10D 44IDX64OD
• 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: 7817925
• Report Number: 1818910-2018-67707
• Device Sequence Number: 2347840
• Product Code: LPH
• UDI-Device Identifier: 10603295016632
• UDI-Public: 10603295016632
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2018

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: 04/15/2015
• Device Catalogue Number: 122144164
• Device Lot Number: EN8FP1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 11/26/2019
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/14/2018; 12/17/2019
• 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