MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 MODULAR CATHCART BALL 46MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Catalog Number 136346000

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

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 revised to address infection and loosening of the stem component at the cement to implant interface.Competitor cement manufacturer was used.The joint was washed out.The endo head and neck were removed.The same stem was recemented and a new head and neck were used.Antibiotic beads were placed, the stem retained was part #157006100/d17101164.Doi: (b)(6) 2018, dor: (b)(6) 2018, right hip.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 46MM OD
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7424716
• MDR Text Key: 105255557
• Report Number: 1818910-2018-57217
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032786
• UDI-Public: 10603295032786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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 Catalogue Number: 136346000
• Device Lot Number: D17092455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 08/01/2018
• Supplement Dates FDA Received: 07/09/2018; 08/31/2018
• Date Device Manufactured: 10/03/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 70