MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121731052
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	12/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received: on (b)(6) 2018, the patient had a minimally invasive cement-free hip tep left to address dysplasia coaxarthrosis left.On (b)(6) 2022, the patient had a revision to address inlay dislocation, metallosis in case of ladle and inlay abrasion (head/liner) prior to the surgery, the patient reported 6 months subluxation phenomena, recurrent falls, squeaking sound, restrictive movement and pain of left hip.During the revision, the surgeon observed severe scarring.On (b)(6) 2024, the patient had a revision with pan change left along with synovectomy of metallosis, pain change.The patient had a twice inlay luxation for cup retention.The patient had a revision, debridement, during the revision, the surgeon observed that the entire joint was black, the liner was was only in the front of the cup (disassociated).The head was not luxated, the inlay had come loose for the 2nd time from the enclosed cement-free cup during a sideways step and was subluxated to mediocaudal.The head was still in the cup.The cup position was regular, no cup loosening, no migration.A purely mechanical problem that the inlay did not hold in the cup.There were no report of surgical delay.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
"the patient did a lunge step ten days ago.Since then she has had pain, movement restrictions, and noises in her left hip.Condition after hip joint implantation in (b)(6) 2018.Revision for inlay dislocation in (b)(6) 2022 (inlay change size 52 standard)".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that hcp is reporting to nca/ bfarm: "the patient did a lunge step ten days ago.Since then she has had pain, movement restrictions, and noises in her left hip.Condition after hip joint implantation in 2018.Revision for inlay dislocation in (b)(6) 2022 inlay change size 52 standard.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the pinn 100 w/gription 52mm exhibits signs of wear on one side inside the implant.Due to the observed damage, it is reasonable to conclude that it was due to a dissociation between the liner and the cup, which caused the head to come in contact with the inner part of the cup.The head shows signs of wear and metal transfer on one side only, which is due to contact with the cup.Based on the unintended interaction of the inner surface of the cup and the femoral head, it is reasonable to conclude that audible sound would be present.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the pinn 100 w/gription 52mm may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A functional test was not performed as it is not applicable to the complaint condition.A dimensional inspection was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pinn 100 w/gription 52mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product description: pinn 100 w/gription 52mm, product code: 121731052, lot number: 8674078.1) quantity manufactured: (b)(4) parts, 2) date of manufacture: 23-nov-2017, 3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot.4) expiry date: 31-10-2027, 5) ifu reference: no information available.Note: dhr information was retrieved from (b)(4) as it is the same lot number.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: hcp is reporting to nca/ bfarm: "the patient did a lunge step ten days ago.Since then she has had pain, movement restrictions, and noises in her left hip.Condition after hip joint implantation in 2018.Revision for inlay dislocation in june 2022 (inlay change size 52 standard)" the product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed that pinn 100 w/gription 52mm is articulating with the femoral head as a result of a disassociation of the liner from the acetabular cup.Based on the unintended interaction of the inner surface of the cup and the femoral head, it is reasonable to conclude that audible sound would be present.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the pinn 100 w/gription 52mm may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device product code and lote, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn 100 w/gription 52mm would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot product description: pinn 100 w/gription 52mm product code: 121731052 lot number: 8674078 1) quantity manufactured: 08 parts 2) date of manufacture: 23-nov-2017 3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot.4) expiry date: 31-10-2027 5) ifu reference: no information available.H10 additional narrative: added: b5.
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 52MM
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18730125
• Report Number: 1818910-2024-03637
• Device Sequence Number: 17920019
• Product Code: KWA
• UDI-Device Identifier: 10603295010203
• UDI-Public: 10603295010203
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 02/19/2024

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 Catalogue Number: 121731052
• Device Lot Number: 8674078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 03/28/2024; 04/16/2024; 04/25/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/01/2024; 04/16/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2017
• 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: ALTRX NEUT 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; DLT TS CER HD 12/14 36MM +5.0; UNK ADAPTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female