MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed on (b)(6) 2020 via tha for the patient¿s right hip joint.It was reported that the patient fell and the fracture around the stem occurred in walking at the hospital on (b)(6) 2020.The revision surgery was performed on (b)(6) 2020 by replacing the stem.The acetabular side implants were remained.The surgeon wrapped a cable around the patient¿s femur and completed the revision surgery.It was unknown whether there was any surgical delay.No further information is available.
Additional 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: TRI-LOCK BPS SZ 2 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10755503
• Report Number: 1818910-2020-23551
• Device Sequence Number: 3333373
• Product Code: KWA
• UDI-Device Identifier: 10603295001041
• UDI-Public: 10603295001041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1012-14-020
• Device Catalogue Number: 101214020
• Device Lot Number: J13K84
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 32 +1 GR; ARTICUL/EZE BALL 32 +1 GR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR