MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 7 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-04-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient, while standing, has had a sudden structural failure.At the emergency room it was diagnosed a rupture of the stem at neck level.A revision surgery has been planned for on (b)(6) 2022.
Additional 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.
Additional 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.
Event or Problem Description
On (b)(6) 2019, the patient had a cementless arthroplasty with ceramic-ceramic bearing (trilock pinnacle depuy), right hip.On (b)(6) 2020, patient had a revision for dislocation of right hip prosthesis and right knee arthroplasty.Femoral head removal during hip revision, with ceramic femoral head implanted (bioball merete for hip) the patient had a right cemented three compartment total arthroplasty attune depuy, right knee on (b)(6) 2020, the patient had a revision, right hip for dislocation dual-mobility stryker mdm psl cup implant and bioball head, cup/head removed.Tritanium psl 64mm with bi-articular insert bioball head, teasta bi-articular coupling (implanted?) on (b)(6) 2022, patient reports mechanical failure of right hip in the absence of pain.The diagnostic conclusion was a rupture, fracture of the metal neck of the stem.
Event or Problem Description
Affected side: right hip.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.All available x-ray and photos provided were reviewed and it was observed that the device was fractured, therefore the allegation can be confirmed.Depuy synthes 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: a manufacturing record evaluation was performed for the finished device (p/n: 101204070, lot: j12t00) and no non-conformances or manufacturing irregularities related to the malfunction were identified.

• Brand Name: TRI-LOCK BPS SZ 7 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• 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: 15112636
• Report Number: 1818910-2022-14209
• Device Sequence Number: 20270694
• Product Code: KWA
• UDI-Device Identifier: 10603295000785
• UDI-Public: 10603295000785
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012-04-070
• Device Catalogue Number: 101204070
• Device Lot Number: J12T00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/01/2022; 08/09/2022; 10/07/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/04/2022; 08/22/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 115 KG