MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 28IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-28-248
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a corail pinnacle thr done under spinal anesthetic on (b)(6) 2022 at (b)(6)hospital.Surgery was uneventful.Patient was returned to the ward.They were then taken to x-ray a number of hours later for a routine post op x-ray.The patient was still under the influence of the spinal anesthetic & her legs got caught in the bed sheets so unfortunately dislocated her hip when being moved for the x-ray.Surgeon went to the ward and did a closed reduction.Hip was reduced but surgeon wasn't happy with feeling of stability he had felt on the table, so decided to bring patient back to theatre for mua under image intensifier (i.I) to determine if further surgery was required.On examination under anesthetic with i.I he decided the patient would need to be opened surgically to change the head & liner.Instruments were reprocessed and the patient was brought back to theatre.Plan was surgeon wanted to change from a 50x28mm lipped liner and 28+1.5 head to a 50x32mm neutral liner with a longer 32mm head.He felt there may be some levering on the lip occurring causing the feeling of instability & felt a 32mm diameter would give more stability without needing the lip.On exposing the hip, the surgeon removed the existing 28+1.5mm head - he then decided to trial a longer 28mm head in case this was all that was needed without having to change the liner as well.He placed the 28+8.5mm trial head onto the corail implant, reduced the hip & put the hip through a rom.He decided a liner change was still likely to be necessary.He dislocated the hip and went to remove the trial head from the stem, but it had slipped off.He reached into the wound to retrieve it but had trouble locating it.After searching for some time, the i.I machine was brought back into theatre to help try to locate it.The head was visible on i.I however the surgeon, nor the assistant could reach it from the thr wound.The surgeon decided to proceed with the change of liner & head and to get the general surgeons at (b)(6) to attempt to retrieve the trial 28mm head the following day through a possible abdominal/inguinal wound.The surgeon felt that removing acetabular osteophytes during the initial surgery, had allowed the trial head to be pushed through the anterior capsule when he was trying to feel for the trial head.The 28mm lipped trial liner was removed and replaced with a 32mm neutral liner and 32+5mm head.The general surgeons the following day weren't happy to proceed so transferred the patient to (b)(6).The orthopedic surgical team at (b)(6) were also not happy to intervene so after discussion with colleagues in (b)(6) then transferred the patient to (b)(6) hospital where a pelvic surgeon (with vascular back up available if necessary) proceeded with the surgery on sunday 29/05 and removed the 28+8.5mm trial head.Surgeon later contacted rep on 23/6 to explain what had happened at subsequent revision surgery (at (b)(6)) & what he thought happened in original revision surgery (in (b)(6)).
Additional Manufacturer Narrative
(b)(4).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.
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, d4 (lot, udi), d6b, d10, g4 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d2b, d4 (catalog).
Event or Problem Description
Additional information received: a.Affected side: - left hip.B.Was there any loosening? if yes, on what interface did the loosening occurred? - none reported.C.What is the date of explanation? the patient's primary surgery date was (b)(6) 2022.The patient was revised on the same day (return to theatre on (b)(6) 2022).The trial head was explanted on (b)(6) 2022.
Additional 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: ALTRX LIP LNR 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: 14978047
• Report Number: 1818910-2022-12727
• Device Sequence Number: 5022067
• Product Code: LPH
• UDI-Device Identifier: 10603295016021
• UDI-Public: 10603295016021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 07/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1221-28-248
• Device Catalogue Number: 122128248
• Device Lot Number: J92X20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 09/16/2022; 10/06/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/22/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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: DELTA CER HEAD 12/14 28MM +1.5; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female