MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 26 +4 GR; HIP FEMORAL HEAD

Catalog Number 136501000

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Cancer (3262); Metal Related Pathology (4530)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.The device catalog number is unknown; therefore, udi is unavailable.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.

Event Description

Patient initiated complaint: it was reported by the patient that, "i have a few manufacturing questions about my depuy hip replacement with acetabular shell.Please give me a call at your earliest convenience and e-mail a time frame that works for you." the patient is looking for recall information on the depuy products that she had implanted in her right hip in 2000.The patient reported that she was part of a nova study for hips.The patient reports that she has suffered pain, osteolysis, "multiple bone fractures up and down leg", cancer, and particle disease due to her hip.The patient noted they have a duraloc 100 serious pinnacle cup, enduron poly liner, prodigy stem and arti/cul femoral head.The patient also reports being permanently damaged due to the right hip and will be in a wheel chair within 5 years.The patient also mentioned that she believes her implants were packaged wrong, but did not have specifics as to what that entailed.The patient wants their medical records reviewed and a customer response letter sent.

Event Description

Additional information received indicates that the patient is having an adverse metal reaction and requesting product make-up of the patient's components.

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.H10 additional narrative: added: b5 and h6 (clinical code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The patient was implanted in 2000 and had a revision in 2016, but was uncertain as to what 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.

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; 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.

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 : 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.

Event Description

Additional information was received and stated that the patient's implants were not been recalled.The patient related that she now has systemic metallosis, and a heart condition, and ovarian cancer that she attributed to metallosis.

• Brand Name: ARTICUL/EZE BALL 26 +4 GR
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15950587
• MDR Text Key: 305170391
• Report Number: 1818910-2022-24918
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/09/2022

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 Catalogue Number: 136501000
• Device Lot Number: S5WH61020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/14/2022; 12/22/2022; 01/05/2023; 01/10/2023; 01/20/2023
• Supplement Dates FDA Received: 12/21/2022; 12/27/2022; 01/05/2023; 01/18/2023; 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/1998
• 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: APEX HOLE ELIM POSITIVE STOP; DURALOC 100 SERIES 52MM OD; ENDURON NEUT 52OD X 26ID; PRODIGY SM STAT LNG RT 13.5MM; UNK HIP ACETABULAR CUP DURALOC; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER POLY; UNK HIP FEMORAL STEM PRODIGY
• Patient Outcome(s): Required Intervention