MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP BONE SCREW

Catalog Number UNK HIP BONE SCREW

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

Event Type  Injury  

Event Description

Revision completed due to poly liner detaching from pinnacle cup.Surgeon explanted liner and head.Upon checking the cup surgeon found 2 screws that were not seated properly.The surgeon secured the screws and a new liner was implanted.Doi: (b)(6) 2020; dor: (b)(6) 2022; affected side: right hip.

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.

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

Revision completed due to poly liner detaching from pinnacle cup.Surgeon explanted liner and head.Upon checking the cup surgeon found 2 screws that were not seated properly.The surgeon secured the screws and a new liner was implanted.Doi: (b)(6) 2020; dor: (b)(6) 2022; affected side: right hip.

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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP BONE SCREW
• Type of Device: BONE SCREW
• 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 dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13585635
• MDR Text Key: 286009676
• Report Number: 1818910-2022-03392
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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 Catalogue Number: UNK HIP BONE SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX48OD.; DELTA CER HEAD 12/14 32MM +.; PINN SECTOR W/GRIPTION 48MM.; UNK HIP BONE SCREW.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR