MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103540000

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Calcium Deposits/Calcification (1758); Fall (1848); Fatigue (1849); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Claim letter received.Patient alleges pain, hip prosthesis failure, ring on bipolar head broke and suffer from "drop foot".Doi: unknown, dor: unknown, left hip.

Event Description

After review of medical records in addition to what previously alleged patient alleged pain, fall, numbness, tingling, weakness, walking difficulty and having blood clot after second revision surgery.Patient fell and fractured his constrained liner causing his hip dislocate.Radiograph reported of calcification.Constrained liner was revised.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 03-dec-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update (b)(6) 2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : dhr review: a manufacturing record evaluation (nc search) was performed for the finished device 103540000, lot jc0224, and no non-conformances / manufacturing irregularities were identified.

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 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 03-dec-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : dhr review: a manufacturing record evaluation (nc search) was performed for the finished device 103540000, lot jc0224, and no non-conformances / manufacturing irregularities were identified.Corrected: h6 (patient).

• Brand Name: SELF CENT HIP 40X28 RUST
• Type of Device: 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12664305
• MDR Text Key: 277357425
• Report Number: 1818910-2021-22998
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103540000
• Device Lot Number: JC0224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIPOLAR HEAD; SELF CENT HIP 40X28 RUST; SMITH & NEPHEW; SMITH & NEPHEW; UNKNOWN HIP CONSTRAINED ACETABULAR LINERS; UNKNOWN HIP CONSTRAINED ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male