MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 16X10X130 30; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900529210

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Date 09/02/2020

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 primary surgery was performed on an unknown date via tha.It was reported that the revision surgery was performed on (b)(6) 2020 due to armd.The armd was caused by trunnions at the point of head neck junction.The surgeon planned to remove all implants and to replace them as preoperative planning, however, during the surgery, the surgeon could not remove the stem.The stem was pulled about 8mm but was not pulled any more.The surgeon tried to remove the stem about 1 hour, and he abandoned to remove the stem.The stem was remained in the body.It was inferred that the difficulty in removing the stem was caused by bone¿s penetration into the slot of distal stem.The surgeon replaced the liner, the head and the hole-eliminator.The inside of explanted head was blackening.The black ring was seemed at the neck.The surgeon replaced the head with a delta head.The pseudotumor was occurred due to armd.The difficulty removing the stem caused extension of surgical duration and increase of bleeding.The surgery was completed with over 30 minutes delay.There was suspicion of infection, the surgeon might perform another surgery again depending on pathology exam of tissue inside the joint.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached photographs could not confirm the reported allegations.The root cause could not be determined.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.

• Brand Name: SROM 9/10 16X10X130 30
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10541089
• MDR Text Key: 207166681
• Report Number: 1818910-2020-20216
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• 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: 09/01/2020

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: 900529210
• Device Lot Number: 3308831
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 28MM +3; APEX HOLE ELIM POSITIVE STOP; PINN MAR ETO LIP LNR 28IDX50OD; 9/10 COCR HEAD 28MM +3; APEX HOLE ELIM POSITIVE STOP; PINN MAR ETO LIP LNR 28IDX50OD
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR