MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC PRESS FIT SZ 4; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-05-100

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/02/2021

Event Type  Injury  

Event Description

It was reported that patient was revised due to dislocation.Doi: (b)(6) 2021-dor: (b)(6) 2021(unk hip).Additional information received on (b)(6) 2021 in response to: "with regards to this, please confirm if any of the following information is available: kindly indicate the affected side (left/right hip).Please provide reason why the stem was also revised.Was the stem loosed, malposition or has any deficiency that contributed the dislocation event.Are the products being returned? if yes, please it to the address below." which they replied: "it was her right hip, there was no deficiency with the stem but it was loose.He products are not being returned.

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).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.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: SUMMIT BASIC PRESS FIT SZ 4
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU)LTD 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13044030
• MDR Text Key: 286645147
• Report Number: 1818910-2021-28461
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295059707
• UDI-Public: 10603295059707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-05-100
• Device Catalogue Number: 157005100
• Device Lot Number: D19014071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/27/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +1.5 GR.; SELF CENT HIP 50X28 BRN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female