MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 14X9X125 30+4 S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900549210

Device Problems Fracture (1260); Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Not Applicable (3189); No Code Available (3191)

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 (b)(6) 2016 via tha. It was reported that it was confirmed the stem (p/n: 900525210) and the sleeve (p/n: 550504) fracture by x-ray when the patient visited to the hospital on (b)(6) 2019, and the patient¿s condition was unwalkable. Thus, the revision surgery was scheduled to be performed in the near future (date of surgery was not fixed yet). Possible cause: the implants in question had been placed in a little bit varus at the primary surgery. No further information is available.

Manufacturer Narrative

Product complaint # (b)(4). (b)(4) used to capture the surgical intervention and medical device removal.

Event Description

Additional information received confirmed that there was a 30 minute surgical delay.

• Brand Name: SROM 9/10 14X9X125 30+4
• 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
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9505554
• MDR Text Key: 173980745
• Report Number: 1818910-2019-124447
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 900549210
• Device Lot Number: 8252270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/20/2019 Patient Sequence Number: 1