MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SUMMIT

Catalog Number UNK HIP FEMORAL STEM SUMMIT

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.(b)(4).

Event Description

It was reported that the patient had a hip fracture on (b)(6) 2020, and a summit basic unipolar hemi arthroplasty.The patient returned to surgery today due to a painful hip and loosening of the stem at bone to implant interface and revision to a cemented summit total hip.Doi: (b)(6) 2020, dor: (b)(6) 2020, left hip.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10808852
• MDR Text Key: 215279553
• Report Number: 1818910-2020-24166
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM SUMMIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (0 NECK); (45 MOD CATHCART)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR