MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number 1554-02-165

Device Problems Inadequacy of Device Shape and/or Size (1583); Osseointegration Problem (3003); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

It was reported that the patient was experiencing a lot of pain.Stem subsided, surgeon believed it to be infected but it was not.Stem looked undersized on original xray.Liner swapped and larger stem implanted with new head.Original size was 16.5 lg, implanted a 19.5 lg.It was also indicated that there was loosening of the stem at the bone to implant interface.Doi: (b)(6) 2018; dor: (b)(6) 2021; affected side: 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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: AML LG STATURE 16.5MM
• Type of Device: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12010164
• MDR Text Key: 256533432
• Report Number: 1818910-2021-12815
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295058380
• UDI-Public: 10603295058380
• Combination Product (y/n): N
• PMA/PMN Number: K012364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1554-02-165
• Device Catalogue Number: 155402165
• Device Lot Number: 293969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR