MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML LG STATURE 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Not Applicable (3189); No Code Available (3191)
Date of Event	11/01/2012
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
New etq created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.Patient was revised to address elevated ion levels.Doi 2009 - dor (b)(6) 2012; (left hip).Update: 6/5/13 - litigation papers received.Litigation alleges pain and hearing loss.Date of implant has also been provided.There is no additional information that would affect the outcome of this investigation.Update: 12/3/2013 - pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Complaint was updated on (b)(6) 2013.The (b)(4) is a reopen of (b)(4) due to receipt of the following information: update apr 18, 2018: ppf and sticker sheets received.Ppf alleges metal wear/metallosis and elevated metal ions confirmed in medical records.There were no medical records provided.Updated the revision hospital and added firm to the complaint.Updated the manufacture dates and added expiry dates for the head and liner products.Added new associated contact added new associated contact and stem product due to the alleged metal poisoning.Doi: (b)(6) 2009 : dor: (b)(6) 2012; (left hip).Patient is bilateral, please see (b)(4).
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.

• Brand Name: AML LG STATURE 15.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7525285
• Report Number: 1818910-2018-59952
• Device Sequence Number: 13766641
• Product Code: JDI
• UDI-Device Identifier: 10603295058373
• UDI-Public: 10603295058373
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: 03/15/2019
• Device Catalogue Number: 155402150
• Device Lot Number: DH9C1A000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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: 64 YR
• Patient Weight: 91