MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZT HA 18D-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 550149

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/02/2020

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

The patient was in pain and had developed a limp. Primary implant date: (b)(6) 2005. Revising a pinnacle asr/srom the surgeon discovered the neck (36 + 12mm) had bent and disconnected from the stem. The original plan was to replace the liner and head from metal on metal articulation to a poly/ceramic or ceramic/ceramic. After opening the surgeon noted that the stem was loose. The neck of the srom stem was disconnected from the stem and sleeve. They replaced the stem with a sized 11 corail kho. The surgeon was able to pull it out with his hand. Rep present. Male patient, id: (b)(6), dob: (b)(6). No delay in the surgery.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• 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: 10155105
• MDR Text Key: 195168672
• Report Number: 1818910-2020-13803
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K912713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 550149
• Device Lot Number: 1209752
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/15/2020 Patient Sequence Number: 1

Treatment

S-ROM*STM STD,30 NK,18X13X160; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD