MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 32 +5 BR; HIP FEMORAL HEAD

Model Number 1365-22-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon reported to bfarm: "hip-tep left side on (b)(6) 2007 in (b)(6).Over the years patient was always without symptoms.Now after a slight stumble-fall there is severe pain in the left hip for weeks.The walking is strongly limited, the walking distance reduced.There is pain at rest, at night as well as severe start-up pain.Painkillers are taken as needed.Radiologically large osteolyses in trochanter major and minor, pe wear.In conjunction with the radiological findings indication for inlay replacement surgery was given.Revision surgery on (b)(6) 2022.".

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
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> 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.Device history lot
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> 1) quantity manufactured: (b)(4).2) date of manufacture: 02/2007 3) any anomalies or deviations identified in dhr: none 4) expiry date: 02/2012 5) ifu reference: 90200701.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code 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).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 : visual examination of the returned device found nothing indicative of a device nonconformance.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot :1) quantity manufactured: 40.2) date of manufacture: 02/2007.3) any anomalies or deviations identified in dhr: none.4) expiry date: 02/2012 5) ifu reference: (b)(4).Device history review : 1) quantity manufactured: 40.2) date of manufacture: 02/2007.3) any anomalies or deviations identified in dhr: none.4) expiry date: 02/2012.5) ifu reference: (b)(4) corrected: h3.

• Brand Name: ARTICUL/EZE BALL 32 +5 BR
• Type of Device: HIP FEMORAL HEAD
• 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: 13719616
• MDR Text Key: 286915981
• Report Number: 1818910-2022-04374
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033189
• UDI-Public: 10603295033189
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K883460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2022

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
• Device Operator: Health Professional
• Device Model Number: 1365-22-000
• Device Catalogue Number: 136522000
• Device Lot Number: 2328452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 02/28/2022; 03/30/2022; 05/05/2022; 05/05/2022; 06/30/2022; 07/05/2022
• Supplement Dates FDA Received: 03/17/2022; 04/04/2022; 05/07/2022; 05/12/2022; 06/30/2022; 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2007
• 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: PINN LINER NEUT 32IDX52OD; PINNACLE 100 ACET CUP 52MM; UNK HIP ACETABULAR HOLE ELIMINATOR; UNK HIP ACETABULAR LINER POLY; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female