MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-052

Device Problem Use of Device Problem (1670)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Distress (2329); Unspecified Tissue Injury (4559)

Event Date 07/03/2022

Event Type  Injury  

Event Description

Pinnacle litigation record received.Litigation alleges subsequent dislocation post revision on (b)(6) 2022 and (b)(6) 2022 leading to re-revision of the left hip.Plaintiff also suffered injury to his muscle, tissue, scar tissue formation, painful dislocation, emotional trauma and distress.Doi: (b)(6) 2022; dor: (b)(6) 2022; left hip second revision.

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.

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.H10 additional narrative: added: b5 and d10.

Event Description

When the patient underwent the revision on (b)(6) 22 (captured on (b)(4)), a depuy synthes poly liner and ceramic head with ts were placed.On 03-jul-2022, the depuy synthes cup, one screw, head, and liner were revised secondary to recurrent dislocations.There is no mention in the operative note as to what the previous treatment was for the recurrent dislocations.Intraoperatively, scarring was identified.The surgeon noted the cup was in increased anteversion.A significant amount of soft tissue destruction was present secondary to metallosis.The surgeon felt the cup anteversion and soft tissue destruction is what led to the recurrent dislocations.Therefore, the cup was also revised.A competitor cup and dual mobility liner/head were placed along with a new depuy synthes head.

Event Description

Medical records were received and stated the following: on (b)(6) 2022 the patient was revised due to metallosis and pain.The patient had depuy dlt ts cer hd 12/14 36mm +1.5 ceramic femoral head, and an altrx +4 10d 36idx52od polyliner implanted.Discharge notes that the patient was revised for metallosis and had cobalt level 102 and chromium level 133 prior to the revision surgery.Aspirations prior to the (b)(6) 2022 were negative for infection.On (b)(6) 2022, medical records note the patient reported intense pain and states any time they move it feels as if her hip wants to pop out of place.On (b)(6) 2022, the patient had a left hip revision to address failed left total hip with recurrent dislocations after revision surgery on (b)(6) 2022.The surgeon reported that during the previous surgery for metallosis, there was significant destruction of the soft tissue which caused how easily the patient was dislocating now.The cup was noted to have been in increased anteversion, so it was revised.The femoral stem was noted to be well fixed and retained.It was noted that on the discharge record the patient had acute blood loss as cause of postoperative anemia.There were no treatments noted, and postoperative anemia is not an unexpected occurrence for a major surgery.Competitor cup with competitor dual mobility liner, and screws were implanted along with depuy femoral head.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Left hip.

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.

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; 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.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• 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: 16589762
• MDR Text Key: 311743948
• Report Number: 1818910-2023-06317
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• 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
• Reporter Occupation: Other
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2018
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: CG2HG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/23/2023; 03/28/2023; 06/08/2023; 09/21/2023
• Supplement Dates FDA Received: 03/23/2023; 04/14/2023; 06/08/2023; 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2008
• 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: BIOLOXDELTA CERAMIC WITH TS HEAD SIZE 36 +1.5; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE SECTOR II CUP 52MM; POLYETHYLENE +4 10 DEGREE; SUMMIT DUOFIX TAP SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White