MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +0; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Date 04/29/2019

Event Type  Injury  

Event Description

Clinical notification received for revision due to aseptic loosening of the femoral stem, pain and stiffness.Date of implant: (b)(6) 2016.Date of revision: (b)(6) 2019.(right hip).Revision of the head, stem and liner.

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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER HEAD 11/13 36MM +0
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14103453
• MDR Text Key: 289195296
• Report Number: 1818910-2022-06702
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033561
• UDI-Public: 10603295033561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1365-36-210
• Device Catalogue Number: 136536210
• Device Lot Number: 8312567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 05/24/2022
• Supplement Dates FDA Received: 05/04/2022; 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2016
• 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 +4 NEUT 36IDX56OD; PINNACLE SECTOR II CUP 56MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM*STM ST,36+8L NK,18X13X160; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male