MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ASPHERE M SPEC 12/14 36 +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136553100
Medical Device Problem Codes	Material Disintegration (1177); Naturally Worn (2988)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994); Distress (2329); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Date of Event	01/13/2017
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
Alleges pain, discomfort, mobility issues, psychological and emotional trauma, elevated metal ions, and mri revealed peritrochanteric fluid collection.After review of medical records for mdr reportability, it was reported that the patient was revised to address chronic pain disability due to the failed hip arthroplasty.Admission notes reported grinding of metal implants released metal ions into the patient's blood.No lab results were provided.Doi: (b)(6) 2009; dor: (b)(6) 2017; left hip.
Additional Manufacturer Narrative
Additional narrative:  (b)(4).Investigation summary no device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges pseudotumor, metal wear, metallosis, and elevated metal ions.
Additional Manufacturer Narrative
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.Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.

• Brand Name: ASPHERE M SPEC 12/14 36 +8.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7366223
• Report Number: 1818910-2018-55999
• Device Sequence Number: 1718798
• Product Code: JDI
• UDI-Device Identifier: 10603295033967
• UDI-Public: 10603295033967
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/28/2018

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: 05/01/2014
• Device Catalogue Number: 136553100
• Device Lot Number: 2927610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/10/2018; 12/28/2018; 07/16/2019
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/17/2018; 01/14/2019; 07/23/2019
• 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
• Patient Age: 68 YR
• Patient Weight: 93