MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOLOX DELTA; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136532330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.E3 initial reporter occupation: lawyer.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
It was alleged that the ceramic head was broken on (b)(6) 2021.Doi: (b)(6) 2020.Dor: unknown.Affected side: unknown.
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 perform 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 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.
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.H11 additional narrative: added: a2 (date of birth).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.According to the information received,"pinnacle claimsuite complaint received ad (b)(6) 2024.It was alleged that the ceramic head broken on (b)(6) 2021.Doi: (b)(6) 2020.Dor: unknown.Affected side: unknown" product description: delta cer head 12/14 32mm +9.Product code: 136532330.Lot no: 9262144.Quantity of manufactured: (b)(4).Date of manufacturing: 24-aug-2019.Expiry date: 31-jul-2024.A manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 32mm +9, product code: 136532330, lot number: 9262144 and no non-conformances / manufacturing irregularities were identified.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 24-aug-2019.3) any anomalies or deviations identified in dhr: no nonconformities associated with this lot.4) expiry date: 31-jul-2024.Device history review: a manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 32mm +9, product code: 136532330, lot number: 9262144 and no non-conformances / manufacturing irregularities were identified.Added: g4 pma/ 510(k).Corrected: h4.
Event or Problem Description
Additional information received states that litigation records alleged breakage and failure of the liner.
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.H11 additional narrative: added: b5, d6b, d10 concomitant.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BIOLOX DELTA
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20426889
• Report Number: 1818910-2024-21367
• Device Sequence Number: 20942657
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Type of Report: Initial,Followup,Followup,Followup,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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 136532330
• Device Lot Number: 9262144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 05/07/2026; 05/13/2026; 06/09/2026
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/22/2024; 05/13/2026; 05/15/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2019
• 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: CORAIL2 STD SIZE 12; PINN MAR +4 10D 32IDX54OD; PINN MULTIHOLE W/GRIPTION 54MM; UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male