MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121725500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 11/01/2022

Event Type  Injury  

Event Description

Updated event description: on (b)(6) 2017, the patient underwent a revision for mom implants captured on the linked pc.On (b)(6) 2018, the patient's left hip dislocated and she underwent a manipulation under anesthesia (captured on this pc, (b)(4)).On (b)(6) 2022, the patient's left hip dislocated again and she underwent a manipulation under anesthesia.On (b)(6) 2022, the patient's left hip dislocated again and she underwent a manipulation under anesthesia.On (b)(6) 2022, the patient was ultimately revised for pain, joint instability, and recurrent dislocations.Intraoperatively, the surgeon identified that the cup was mispositioned by being too lateral and vertical.The ceramic head was scratched due to the prior dislocations.The patient is osteopenic and had insufficiency of her posterior wall (bone) and very poor bone stock surrounding the acetabulum.The posterior capsule was patulous (poor condition).The anterior wall was also insufficient and "cracked" with the use of an explant osteotome during the cup removal.The anterior wall was noted to be crumbling.During the revision, the stem remained in situ.The cup, liner, and head were replaced.The newly placed cup, screws, and liner are noted to be competitor products.Doi: (b)(6) 2017, dor: (b)(6) 2022; affected side; left hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18884808
• MDR Text Key: 337416592
• Report Number: 1818910-2024-05557
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009900
• UDI-Public: 10603295009900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• 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
• Report Date: 03/12/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2018
• Device Catalogue Number: 121725500
• Device Lot Number: C39BW4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 04/19/2024
• Supplement Dates FDA Received: 03/13/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2008
• 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: ALTRX NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; DLT TS CER HD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female