MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 45X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-45-000

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

It was reported that size 45mm bipolar head and 28+8.5mm head would not seat all the way when implant was assembled.The poly portion of the head appears too small and can disassociate poly from head by pressing with fingers.Surgeon did not feel confident implanting the assembled implant so a second implant was opened and didn¿t not have the same issue as the first implant opened and assembled.Doe: (b)(6) 2022.Affected side :left side.

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).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 : visual analysis of the returned sample 103545000/self cent hip 45x28 gry exhibited that metal head was stuck into poly bearing insert so no further analysis on the part could be performed.The reported allegation was not be to be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device (103545000/jt9931 product and lot numbers, and no non-conformances were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : visual analysis of the returned sample 103545000/self cent hip 45x28 gry exhibited that metal head was stuck into poly bearing insert.It was not possible to disassemble devices, a disassociation among femoral head and liner seems hardly possible.No further analysis on the part could be performed.The reported allegation was not able to be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device (103545000/jt9931 product and lot numbers, and no non-conformances were identified.

• Brand Name: SELF CENT HIP 45X28 GRY
• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14717138
• MDR Text Key: 296171989
• Report Number: 1818910-2022-11073
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003359
• UDI-Public: 10603295003359
• 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,Followup,Followup,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-45-000
• Device Catalogue Number: 103545000
• Device Lot Number: JT9931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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 +8.5 BL
• Patient Age: 89 YR
• Patient Sex: Female