MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 7; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-06-135

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6), 2022, the patient underwent a bha surgery for femoral neck fracture.During the surgery, when the surgeon tried to open the package of the implant, the surgeon found that the plastic package on the outer side of the double sterilization package had been broken.The surgeon considered that there was no guarantee that the sterilization of the implant had been maintained.The surgery itself was completed successfully with no surgical delay.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> the device associated with this report was returned for analysis.After visual examination, allegation is confirmed.It was possible to observe that inner packaging presented a breakage and sterility was compromised.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
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> product code 157006135, lot number d14082123 was manufactured on 20-aug-2014.A total of (b)(4) parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is jul-2024.Ifu reference no.Is ifu-0902-00-701.H3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.After visual examination, allegation is confirmed.It was possible to observe that inner packaging presented a breakage and sterility was compromised.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: product code 157006135, lot number d14082123 was manufactured on 20-aug-2014.A total of 16 pcs parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is jul-2024.Ifu reference no.Is ifu-0902-00-701.Device history review: a manufacturing record evaluation was performed for the finished device (157006135/d14082123) product and lot numbers, and no non-conformances were identified.H10 additional narrative: added: d3 (manufacturer email) corrected g4 (pma/ 510(k)).

• Brand Name: SUMMIT BASIC CEMENTED SZ 7
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• 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 46581-0988 ; 3035526892
• MDR Report Key: 14087321
• MDR Text Key: 289185474
• Report Number: 1818910-2022-06626
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295059806
• UDI-Public: 10603295059806
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-06-135
• Device Catalogue Number: 157006135
• Device Lot Number: D14082123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 05/25/2022; 06/21/2022; 08/09/2023
• Supplement Dates FDA Received: 05/26/2022; 06/21/2022; 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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