MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC PRESS FIT SZ 4; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-05-100

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2021

Event Type  Injury  

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 Description

It was reported that the bipolar head and stem were removed due to stem subsidence and possible infection.Loosening of the stem at the bone to implant interface was also reported.Doi: (b)(6) 2020, dor: (b)(6) 2021, unknown side of the 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.Corrected: g1.

• Brand Name: SUMMIT BASIC PRESS FIT SZ 4
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11260079
• MDR Text Key: 229848115
• Report Number: 1818910-2021-02184
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295059707
• UDI-Public: 10603295059707
• Combination Product (y/n): N
• PMA/PMN Number: K030122
• 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: 01/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-05-100
• Device Catalogue Number: 157005100
• Device Lot Number: D20040466
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 53X28 BLU; SUMMIT BASIC PRESS FIT SZ 4
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR