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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Ambulation or Postural Difficulties (2544); Test Result (2695)
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: 12/14 articul 44mm m spec+15.5 hip femoral head; pinnacle mtl ins neut44idx62od hip acetabular liner; unknown hip acetabular cup; aml lg stature 15.0mm hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.
Event or Problem Description
Litigation alleges that patient has experienced pain, difficulty walking, swelling, and elevated metal ion levels.Doi: (b)(6) 2007; dor: none reported; (left hip).Patient is a resident of (b)(6).Update: 12/17/12 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update ad 26 apr 2018: (b)(4) has been reopened under (b)(4) due to receipt of ppf and sticker sheets. there were no new allegations found in the ppf.Added the stem to the impacted products to addressed previous allegation of elevated metal ions.Updated patient codes.Doi: (b)(6) 2007; dor: none reported; (left hip).
Additional Manufacturer Narrative
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. .

• 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 0988
• MDR Report Key: 7868056
• Report Number: 1818910-2018-69066
• Device Sequence Number: 1964375
• Product Code: JDI
• UDI-Device Identifier: 10603295058373
• UDI-Public: 10603295058373
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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 Catalogue Number: 155402150
• Device Lot Number: BP1B11000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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 Weight: 100