MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 40 -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-04-100
Medical Device Problem Codes	Corroded (1131); Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	07/10/2019
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
It was reported that the patient had pain in his left hip, black substance between head and trunion.(2) 6.5 pinnacle screws where removed as well.A 58x36 n liner was impacted and a biolox 36 +1.5 head was impacted.Doi: (b)(6) 2009; dor: (b)(6) 2019; 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).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.H10 additional narrative:.
Event or Problem Description
After review of medical records, patient was revised to address pain.Intraoperative findings reported of large amount of fluid that came from the iliopsoas bursa.There was extensive corrosion between the cobalt chrome aml stem and the cobalt chrome ball.There was also extensive corrosion on the back of the metal insert between the insert and the depuy shell.There was also a metallic debris around the trunnion.The screws removed from the acetabulum as their utility had long since passed and shouldn't complicate for the polyethylene bearing.The 2 unknown hip implant and unknown stem were update.Cup and 1 screw were added due to revision findings.

• Brand Name: ASPHERE M SPEC 12/14 40 -2
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8840666
• Report Number: 1818910-2019-99612
• Device Sequence Number: 10855624
• Product Code: JDI
• UDI-Device Identifier: 10603295032953
• UDI-Public: 10603295032953
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2019

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 Model Number: 1365-04-100
• Device Catalogue Number: 136504100
• Device Lot Number: 2860930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/09/2019; 03/16/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/13/2019; 03/31/2020
• 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: 74 YR
• Patient Weight: 77