MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML SM STATURE 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number 1554-01-135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); No Code Available (3191)

Event Date 04/23/2007

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges patient had pain, disability, physical impairment, disfigurement and aggravation of a pre-existing condition after asr hip implant.After review of medical records, patient was revised to address 1cm leg length discrepancy.Doi: (b)(6) 2006, dor: (b)(6) 2007, (left hip).

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.

• Brand Name: AML SM STATURE 13.5MM
• Type of Device: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9756831
• MDR Text Key: 184812522
• Report Number: 1818910-2020-06034
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295058243
• UDI-Public: 10603295058243
• Combination Product (y/n): N
• PMA/PMN Number: K012364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/24/2012

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
• Device Operator: Health Professional
• Device Model Number: 1554-01-135
• Device Catalogue Number: 155401135
• Device Lot Number: ZB5GV1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR