MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 52X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103552000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.
Event or Problem Description
It was reported that the patient underwent a second total hip revision.Coral stem has fractured at the neck region.According to the surgeon, the patient did not have a fall, was simply stretching to put his pants on and felt it give way.Surgeon also stated that the patients posterior hip capsule was deficient.The patient had previously complained of groin pain and had seen two other surgeons in relation to this for hip arthroscopies where they performed psoas tendon releases.Stem was very well fixed and took considerable effort to remove from the femoral canal.Patients original surgery was for a hemiarthroplasty bipolar for a fractured neck of femur.This was later revised to a total hip with the femoral stem left in situ and the acetabular converted from a bipolar to a pinnacle thr.Affected side: right hip this report captures the first revision.
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: d4 (lot, catalog, expiry date, primary udi number), d10 (concomitant), g4 [pma/ 510(k)], h4.Corrected: d1, d2a, d2b.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that: what was the exact reason for the revision of head and poly? conversion of hemiarthroplasty to total hip due to progression of osteoarthritis (original surgery was done for fracture nof).
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
Clinician review 10-03-2025: agree that this should be converted to npi.The event describes primary implantation of a hemiarthroplasty hip construct due to patient having sustained a non-product related femoral neck hip fracture.No product allegations, event occurred prior to any implants being present.

• Brand Name: SELF CENT HIP 52X28 BLU
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22848173
• Report Number: 1818910-2025-14507
• Device Sequence Number: 11852734
• Product Code: KWY
• UDI-Device Identifier: 10603295003427
• UDI-Public: (01)10603295003427(17)190601(10)547095
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 103552000
• Device Lot Number: 547095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 09/04/2025; 09/12/2025; 09/17/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/07/2025; 09/15/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2014
• 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: ARTICUL/EZE BALL 28 +1.5 GR; CORAIL AMT COLLAR SIZE 11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male