MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH; PROSTHESIS, HIP

Model Number	6250-65-70
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A2: year of birth: 1938.Concomitant medical products: burch-schneider, reinforcement cage, new, left, 56: catalog#0100191156, lot#3145853; durasul, low profile cup, cemented, 56/36: catalog#0595001054, lot#3076489; bone screw self-tapping 6.5 mm dia.70 mm length : catalog#00625006570, lot#63486224; cocr head, l, 㸠36/+4, taper 12/14: catalog#0101012367, lot#3043232; fitmoreâ®, hip stem, uncemented, offset b (extended)/8, taper 12/14: catalog#0100551308, lot#3142451.G2: foreign: germany two (2) screws have been reported for this event.At the time of this report, it is unknown which screw is implicated in the adverse event.Both have been reported under the following associated report: 0002648920-2023-00088.The product will not be returned for evaluation as it remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow up mdr will be submitted.
Event or Problem Description
It was reported a patient underwent an initial total hip arthroplasty.When placing the bone screw in the acetabular region, it was noticed that the screw head slipped through the hole in the implant and came to rest behind the implant during final tightening.There was a delay of 120 minutes while the surgeon attempted to remove the screw, but was unable.The screw remains in the patient.Due diligence is in process for this complaint; to date no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: b-s reinforcmnt ring new 56 lt: catalog#01.00191.156, lot#3145853; durasul, low profile cup, cemented, 56/36: catalog#0595001054, lot#3076489; bone screw self-tapping 6.5 mm dia.70 mm length : catalog#00625006570, lot#63486224; cocr head, l, 㸠36/+4, taper 12/14: catalog#0101012367, lot#3043232; fitmoreâ®, hip stem, uncemented, offset b (extended)/8, taper 12/14: catalog#0100551308, lot#3142451; unknown sponiosa screw: catalog#418.070, lot#ni; unknown sponiosa screw: catalog#418.075, lot#ni; unknown sponiosa screw: catalog#418.050, lot#ni; unknown bone cement: catalog#ni, lot#ni.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Event or Problem Description
It was reported that during an initial left hip arthroplasty, a screw slipped through the hole and emerged past the cage.The screw was able to be removed without incident and was replaced with a competitor's screw which also slipped and remains implanted.Operative notes indicated that the reported device did not cause or contribute to the previously reported patient impact and serious injury.Due diligence is complete as multiple attempts have been made however it was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroplasty was performed where 2 6.5mm screws were placed for fixation of a cage.One screw emerged past the cage, and thus was removed and replaced with a competitor's screw that slipped through the cage as well and remains implanted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty, also with acetabular reconstruction.Lateral most screw along the superior acetabular component may have slipped through the hole but difficult to evaluate on these images.This is likely of no clinical significance.This is likely related to the 8mm competitor's screw that slipped through the hole and remains implanted.This complaint has been confirmed based on the provided medical records.The root cause of the reported issue is attributed to user error, as the screw and cage used together are not compatible.A summary of the investigation was sent to the complainant regarding proper use of the device and authorized combinations.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16875608
• Report Number: 0002648920-2023-00089
• Device Sequence Number: 5718125
• Product Code: LPH
• UDI-Device Identifier: 00889024119871
• UDI-Public: (01)00889024119871(17)260930(10)63486223
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2023

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 Expiration Date: 09/30/2026
• Device Model Number: 6250-65-70
• Device Catalogue Number: 00625006570
• Device Lot Number: 63486223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 07/06/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/22/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 90 KG