MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 9/10 COCR HEAD 28MM -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-057
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This pc is related to (b)(4) which reports the breakage of the liner after the revision surgery.This pc reports dislocation which is the reason for the revision surgery after the primary surgery.It was reported that on (b)(6) 2011, the primary surgery was performed with the implants in question.After the surgery, the dislocation was confirmed.The event date is unknown.The revision surgery was performed on (b)(6) 2016, to replace the liner, the head and the stem.No further information is available.
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).Investigation summary : no device associated with this report was received for examination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.¿.
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 : no device associated with this report was received for examination.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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the records indicate that this material was manufactured by your symmetry medical facility that was in new bedford, ma.The information is: 1) quantity manufactured: (b)(4), 2) date of manufacture: 12/21/2010, 3) any anomalies or deviations identified in dhr: none noted in the dhr.4) expiry date: n/a, 5) ifu reference: (if applicable) n/a.

• Brand Name: 9/10 COCR HEAD 28MM -3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17320973
• Report Number: 1818910-2023-14256
• Device Sequence Number: 17868318
• Product Code: JDI
• UDI-Device Identifier: 10603295276623
• UDI-Public: 10603295276623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• 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): 07/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2016
• Device Model Number: 1521-90-057
• Device Catalogue Number: 152190057
• Device Lot Number: 3299983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 09/04/2023; 09/18/2023; 04/30/2024
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/05/2023; 09/22/2023; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR ETO NEUT 28IDX50OD; PINNACLE MULTIHOLE II CUP 50MM; S-ROM*SLEEVE PRX ZTT, 20F-XXL; SROM 9/10 20X15X145 36
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown