MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-060

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Distress (2329); Discomfort (2330); Numbness (2415); Swelling/ Edema (4577)

Event Date 08/03/2021

Event Type  Injury  

Event Description

The patient was revised due to metal ion elevated blood levels.Doi: unknown.Dor: (b)(6) 2021.(left hip).Update ad 11 jul 2022: in relation to aei note (b)(4), (b)(4)has been re-opened due to pinnacle mom litigation record received.Litigation alleges metal poisoning due to elevated metal ions resulting to hip pain, discomfort, thick capsule and fluid in the left hip, metal debris, removal of the large amount of brown intra-articular fluid, excision of metallosis tissue around the acetabular cup, debridement of metallosis tissue around the metal liner and neck, emotional trauma and distress.

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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.No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

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.

Event Description

Medical records received.After review of the medical records, the patient was revised to address metallosis, and debridement of synovium.Depuy bearing and head exchange from metal on metal to ceramic on poly.Mri showed thickened capsule and fluid in the left hip region.The operative note reported a large amount of brown intra-articular fluid.There was metallosis debris removed from the cup.Clinical visit reported groin, chronic hip pain, discomfort, metallosis, elevated metal ions and back pain.The patient was treated in late 2020 for left hip flexor strain & l inguinal pain and strain.Doi: (b)(6), 2010; dor: (b)(6), 2021; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint.In order to observed implant wear, photo evidence of the explanted device is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).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).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.

Event Description

After review of medical records, medical reported on (b)(6) 2021, the patient was revised due to metallosis of the hip.Surgical notes reported that the patient begun to experience pain and discomfort.Work up revealed an increased med alliance and blood mri showed thick capsule.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint.In order to observed implant wear, photo evidence of the explanted device is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint or found anything indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

The patient was revised to address metallosis, debridement of synovium.Depuy bearing and head exchange from metal on metal to ceramic on poly.Mri showed thickened capsule and fluid in the left hip region.Operative note reported large amount of brown intra-articular fluid.There were metallosis debris removed from cup.Clinical visit reported groin, chronic hip pain, discomfort, metallosis, elevated metal ions and back pain.Patient was treated in late 2020 for left hip flexor strain & l inguinal pain and strain.Doi: (b)(6) 2010.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint or found anything indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received and stated that there was a shoulder arthroplasty undergone by the patient, however, the devices utilized were competitors.

• Brand Name: PINNACLE SECTOR II CUP 60MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 15096175
• MDR Text Key: 296515304
• Report Number: 1818910-2022-13932
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009863
• UDI-Public: 10603295009863
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/25/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-060
• Device Catalogue Number: 121722060
• Device Lot Number: EV9F31000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 01/11/2023; 01/23/2023; 02/10/2023; 03/01/2023; 03/09/2023; 05/25/2023; 08/04/2023; 08/04/2023; 08/29/2023
• Supplement Dates FDA Received: 01/20/2023; 01/24/2023; 02/20/2023; 03/08/2023; 03/09/2023; 05/25/2023; 08/07/2023; 08/07/2023; 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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: 12/14 ARTICUL 40MM M SPEC+5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX60OD; SUMMIT POR TAPER SZ7 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 127 KG