MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 48X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-48-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 01/22/2023

Event Type  Injury  

Event Description

Patient was revised due to the hip unfortunately dislocated.The surgeon tried for a closed reduction and was unsuccessful.He felt there may be some soft tissues in the joint space that was causing instability of the bipolar.When opening the hip, tissue impingement was confirmed.He felt the patient may have been a little short as well, so he trialed a 48 bipolar head with a 28 +8.5 head and found the hip to be more stable.The real bipolar and 28 head was opened and implanted.The hip was reduced and stability was confirmed.The closing process began.There was no surgical delay.Doi: (b)(6) 2023, dor: (b)(6) 2023, affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SELF CENT HIP 48X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16277863
• MDR Text Key: 308553281
• Report Number: 1818910-2023-02608
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003380
• UDI-Public: 10603295003380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-48-000
• Device Catalogue Number: 103548000
• Device Lot Number: M1146K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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: ARTICUL/EZE BALL 28 +1.5 GR
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male