MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 ASPHERE M SPEC 12/14 40 +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-06-100
Medical Device Problem Codes	Naturally Worn (2988); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Tissue Damage (2104); No Code Available (3191)
Date of Event	05/22/2018
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
Der states that the patient had a metal on metal total hip implanted by the surgeon in 2009.Surgeon revised the metal on metal components due to pain from the metal bearing.There were no signs of infection present.The patient did have tissue around the joint that was consistent of metallosis reaction.Surgeon replaced the explanted parts with a 56x36 +4/10* liner and a 36+5 ceramic head.Surgeon was advised that it would be off label to us a ceramic head without a revision sleeve.He acknowledged and wanted to proceed with a primary ceramic head.Doi: (b)(6) 2009; dor: (b)(6) 2018 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, 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.  h6 patient code: no code available (3191) used to capture device replacement or revision patient code.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 review of medical records, it was stated that the patient was revised to address pain and metallosis with trunnion wear.Patient had a fall 8 months ago then begun experiencing pain.Revision notes reported extensive synovitis, foreign body wear debris(metallosis), and trunnion wear and staining.Doi: (b)(6) 2008; dor: (b)(6) 2018; 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ASPHERE M SPEC 12/14 40 +5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7604772
• Report Number: 1818910-2018-62269
• Device Sequence Number: 11279396
• Product Code: JDI
• UDI-Device Identifier: 10603295032991
• UDI-Public: 10603295032991
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K08585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2018

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: 06/30/2014
• Device Model Number: 1365-06-100
• Device Catalogue Number: 136506100
• Device Lot Number: 2932405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 03/17/2020; 03/15/2021
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/18/2018; 04/06/2020; 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 40 +5; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM; SUMMIT DUOFIX TAP SZ8 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 118