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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Off-Label Use (1494)

Patient Problem Pain (1994)

Event Date 07/16/2021

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 on (b)(6) 2003, the primary surgery was performed with the stem, head and cup.The patient was in his 30s at the time.On (b)(6) 2021, the revision surgery was performed due to pain.In the revision, the head and cup were removed together.When the surgeon tried to remove the stem, the stem couldn¿t be removed.When the surgeon grabbed the stem neck, the stem neck was damaged.The surgeon gave up removing the stem and move to head selection, but there were few variations of heads that could be selected.The patient was young in his 50s, but the surgeon had no choice but to choose a metal head.The placement position of the cup also needed to be adjusted according to the stem currently in place, and thus, could not be placed at the optimum position.The movement of the implant is slightly tight, which is worrisome.Consequently, optimal treatment could not be provided.The surgery was completed with more than 30minutes delay.The surgeon commented as follows.With head variation, he was able to provide optimal treatment for patients without increasing operation time.Although it is a discontinued product, it is the present time to make a revision, and it seems that the fact that there are few variations in the head does not fulfill the responsibility of the manufacturer.Even if revenue cannot be expected, the manufacturer should have additional options to deal with various revisions.No further information is available.

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 device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12288681
• MDR Text Key: 265415046
• Report Number: 1818910-2021-17317
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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 Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: S-ROM*HEAD FEMORAL COCR 28+6; SELF CENT HIP 50X28 BRN; UNKNOWN HIP FEMORAL STEM; S-ROM*HEAD FEMORAL COCR 28+6; SELF CENT HIP 50X28 BRN; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention