MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-048
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2020
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
Due to covid lockdown, case was made aware of a suspected fractured delta ceramic liner with a patient 18 months post operation (this would have been a very rare event in relation to delta ceramics) having requested the hospital looked into the patients notes it was confirmed that it was a 48mm gription 100 pinnacle shell ((b)(4)) with a altrx 48 x 32mm +4mm / 10 degree liner ((b)(4)) we prepared for the removal of the cup, exchange of the liner & brought in delta ts ceramic heads for the case.Upon entering the surgical site, it was clear that the liner had fully disengaged from the cup the upper edge of the cup had broken away for the main body & the ard (anti rotational devices) had worn away.The site contained a small amount of metal debris.The liner was retrieved & the socket was fully cleaned up.Upon inspecting the cup it was felt it was sitting in the correct position & was solid, there appeared to be no sign of damage.A decision was made to replace the liner only leaving the cup intact, a new head would be placed on the stem which also was to remain.A replacement altrx 48 x 32 +4mm / 10 degree liner was placed in situ with a 32mm delta ceramic ts +5 head.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : 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.Device history lot : no device associated with this report was received for examination.Based on the received liner, the reported allegation could be confirmed.The information received will be retained for potential series investigations if triggered by trend analysis 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.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN 100 W/GRIPTION 48MM
• 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 drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10476742
• Report Number: 1818910-2020-19163
• Device Sequence Number: 2438975
• Product Code: JDI
• UDI-Device Identifier: 10603295010180
• UDI-Public: 10603295010180
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2020

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 Model Number: 1217-31-048
• Device Catalogue Number: 121731048
• Device Lot Number: 8708557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/15/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 12/07/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/15/2020; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• 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: 32MM DELTA CERAMIC TS +5 HEAD.; ALTRX +4 10D 32IDX48OD.; APEX HOLE ELIM POSITIVE STOP.; ARTICUL/EZE BALL 32 +9 BL.; CORAIL AMT SZ11 135 HIGH COL.; UNKNOWN HIP FEMORAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female