MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-32-060
Medical Device Problem Codes	Loss of Osseointegration (2408); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the corail stem.Trunion broke off the body of the stem.Doi: (b)(6) 2014.Dor: (b)(6) 2020; affected side: unknown.
Event or Problem Description
After review of the medical records, the patient was revised to address right failed total hip arthroplasty for femoral component fracture.Operative note reported of broken head and trunnion and possible locking mechanism issue of the cup and liner.It was also indicated that there was a metal debris from the removal of the stem.Added facility name and legal attorney.The head and liner that were implanted on (b)(6) 2015 was reported under (b)(4).Doi: (b)(6) 2014.Dor: (b)(6) 2020.Right hip (second revision).
Additional 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.E3 initial reporter occupation: lawyer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update (b)(6) 2022: the investigation was re-opened to review x-ray images that were received on a physical disc.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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: 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Mrn 1818910-2020-20562 is being retracted since it was found to be a duplicate of mrn 1818910-2021-17955.Mrn 1818910-2021-17955 will be kept for investigation purposes.

• Brand Name: PINN SECTOR W/GRIPTION 60MM
• Common Device Name: 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: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10561892
• Report Number: 1818910-2020-20562
• Device Sequence Number: 19527771
• Product Code: LPH
• UDI-Device Identifier: 10603295010340
• UDI-Public: 10603295010340
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 1217-32-060
• Device Catalogue Number: 121732060
• Device Lot Number: 541368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 04/27/2021; 06/09/2021; 02/16/2022; 06/30/2023
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 05/17/2021; 06/10/2021; 02/16/2022; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL AMT COLLAR SIZE 13; UNKNOWN HIP ACETABULAR LINERS(POLY LINER); UNKNOWN HIP FEMORAL AUGMENT (TITANIUM SLEEVE); UNKNOWN HIP FEMORAL HEAD(CERAMIC HEAD); CORAIL AMT COLLAR SIZE 13; UNKNOWN HIP ACETABULAR LINERS(POLY LINER); UNKNOWN HIP FEMORAL AUGMENT (TITANIUM SLEEVE); UNKNOWN HIP FEMORAL HEAD(CERAMIC HEAD)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 109 KG